Drug Companies are Reminded - FDA is Following Facebook

Our Life Sciences Legal Update blog reports today that the FDA’s Office of Prescription Drug Promotion has warned a Swiss drug company about statements the company made on its Facebook page, suggesting that consumers talk to their doctor about a drug without disclosing the risks associated with the product (risks serious enough to require a boxed warning on the label). The FDA action is a reminder that that FDA’s advertising and promotion rules apply regardless of how or where the product is promoted, and the FDA is monitoring social media sites for such activities. For more information, see the full post.

FDA to Overhaul an OTC System That "Isn't Working"

This post was written by Kevin M. Madagan and Jillian W. Riley

The Food and Drug Administration (FDA) has just announced that it will hold a public hearing March 25 and 26, 2014 to obtain input on the Agency’s current process for reviewing over-the-counter (OTC) drugs. This is a significant advancement in FDA’s long-standing plan to overhaul the OTC drug system. According to the announcement, the Agency’s OTC drug review “needs a critical examination at this juncture to examine whether and how to modernize its processes and regulatory framework.”

Teeing up the importance of the public hearing, Dr. Janet Woodcock, the Director of FDA’s Center for Drug Evaluation and Research (CDER), informed the Wall Street Journal that the Agency was “looking for creative ideas about how to improve the process.”1 According to Dr. Woodcock, “The current system isn’t working well for the public or for us.”  Additional details are available after the jump.

Continue Reading...

FDA Provides Direction on "Dear Doctor" Letters

This post was written by Jillian W. Riley.

On January 16, 2014, the Food and Drug Administration (FDA) issued a final guidance document for industry providing specific recommendations on the content and format of Dear Health Care Provider (DHCP or “Dear Doctor”) letters. DHCP letters are an important means of communicating new information to the health care provider community about a product that is already on the market. The guidance provides insight into (1) when to send a DHCP letter, (2) what information should be included, (3) how to organize the letter, and (4) how to format the letter. The recent guidance finalizes a draft guidance FDA published in November of 2010. 

The guidance stresses the importance of collaborating with FDA when crafting DHCP letters to ensure that a DHCP letter is appropriate under the circumstances, that the target audience has been identified, and that the message is clearly conveyed. Additionally, the guidance provides template examples to aid industry in drafting a clear and effective DHCP letter.

FDA Seeks Comments on Drug Company Social Media Guidance

As reported on our Life Sciences Legal Update blog, the FDA has issued draft guidance addressing the unique challenges of drug promotion in the age of social media. Specifically, the draft guidance addresses how to submit interactive promotional media for postmarket review.  Comments on the document, “Draft Guidance for Industry on Fulfilling Regulatory Requirements for Postmarketing Submissions of Interactive Promotional Media for Prescription Human and Animal Drugs and Biologics,” are due April 14, 2014.

FDA Releases Final Guidance on Qualification Process for Drug Development Tools

This post was written by Jennifer Pike.

The Food and Drug Administration (FDA) has announced the availability of a final guidance document which describes the qualification process for drug development tools (DDTs) intended for use, over time, in multiple drug development programs. DDTs are methods, materials, or measures that aid drug development. Examples of DDTs include biomarkers and patient reported outcome instruments.

The purpose of the guidance document is to describe the formal process that FDA will use in working with sponsors of DDTs to guide them as they refine the tools and rigorously evaluate them for use in the regulatory process. The guidance also provides a framework for interactions between FDA and sponsors to support work towards qualification of DDTs, as well as explains the kinds of data that should be submitted to support qualification of a DDT and creates a mechanism for FDA’s formal review of the data to ultimately qualify the DDT. For purposes of the guidance, the submitter of a DDT is the person, group, organization (including the federal government), or consortium that takes responsibility for and initiates a DDT qualification proposal using the procedures described in the guidance.

The creation of the DDT qualification process is one of multiple initiatives FDA has undertaken, as a result of its 2004 FDA’s Critical Path Initiative, to support the development of new DDTs. DDTs can help streamline the drug development process, improve the chances for clinical trial success, and yield more information about a treatment or disease. Comments to the guidance may be submitted at any time at www.regulations.gov.

New Draft Guidances from FDA Address Expedited Review, Safety Labeling and More

This post was written by Jennifer Pike

The FDA has recently issued a number of new draft guidance documents that provide insight on a range of issues, including expedited drug review programs, medical device reporting, importation of unapproved drugs for market launch, and safety labeling changes. A brief summary and link to each draft guidance document is provided below:

  • Expedited Programs for Serious Conditions: Drugs and Biologics – This draft guidance provides a single resource for information on policies and procedures related to FDA’s expedited drug development and review programs: fast track designation, breakthrough therapy designation, accelerated approval, and priority review. The draft guidance is intended to help industry better understand each program, including when the programs can be used and the features of each.
  • Medical Device Reporting for Manufacturers – This draft guidance describes and explains the current FDA regulation that addresses reporting and recordkeeping requirements applicable to manufacturers of medical devices for certain device-related adverse events. The document provides answers to frequently asked questions and includes a section on common reporting errors.
  • Pre-launch Activities Importation Request – This draft guidance describes FDA’s policy regarding requests for the importation of unapproved finished dosage form drug products by an applicant preparing the product for market launch, based on anticipated approval of a pending application (e.g., NDA, ANDA, BLA). It also describes the procedures for making such requests and the factors that FDA will consider in granting such requests.
  • Safety Labeling Changes: Implementation of Section 505(o)(4) of the FD&C Act– Section 505(o)(4) of the Federal Food, Drug, and Cosmetic Act, which was added by section 901 of the Food and Drug Administration Amendments Act of 2007, authorizes FDA to require certain drug and biological product application holders to make safety-related labeling changes based on new safety information that becomes available after approval of the drug or biological product. This draft guidance explains how FDA intends to implement section 505(o)(4), including a description of the types of safety labeling changes that ordinarily might be required under this section, how FDA plans to determine what constitutes new safety information, the procedures involved in requiring safety labeling changes, and enforcement of the requirements for safety labeling changes.

Draft FDA Guidance Recommends Cybersecurity Risk Assessments and Management Plans for Premarket Medical Device Submissions

This post was written by Kevin Madagan and Jennifer Pike.

The Food and Drug Administration (FDA) has announced the availability of a new draft guidance document entitled "Content of Premarket Submissions for Management of Cybersecurity in Medical Devices." The draft guidance identifies cybersecurity issues that medical device manufacturers should consider in preparing premarket submissions for medical devices – including Premarket Notifications (510(k)), Premarket Approval Applications (PMA), Product Development Protocols (PDP), and Humanitarian Device Exemption (HDE) submissions– in order to provide effective cybersecurity management and to reduce the risk that device functionality is intentionally or unintentionally compromised. The draft guidance highlights the need for effective medical device cybersecurity given "the increasing use of wireless, Internet- and network-connected devices and the frequent electronic exchange of medical device-related health information."

FDA’s draft guidance relates to a recommendation by the Government Accountability Office (GAO) in August 2012 that FDA develop and implement a plan to expand its focus on information security risks, with a particular focus on security risks resulting from intentional threats (e.g., hacking, malware).

Comments on the draft guidance should be submitted in writing, or online at www.regulations.gov, by September 12, 2013.

In a related matter, FDA recently released two Safety Communications (available here and here) concerning cybersecurity for medical devices and hospital networks. The Safety Communications recommend that medical device manufacturers and health care facilities take steps to reduce the risk of failure due to cyberattack, which could be initiated by the introduction of malware into the medical equipment or unauthorized access to configuration settings in medical device and hospital networks. Specifically, the Safety Communications recommend the following:

  • Device Manufacturers.  Device manufacturers should "remain vigilant" about identifying risk and hazards and take "appropriate steps" to reduce the risk of device failure due to cyberattack. This includes reviewing cybersecurity practices and policies to "assure that appropriate safeguards are in place," such as:

--Taking steps to limit unauthorized device access to trusted users only, particularly for those devices that are life-sustaining or could be directly connected to hospital networks;

-- Protecting individual components from exploitation and developing strategies for active security protection appropriate for the device’s use environment;

-- Using design approaches that maintain a device’s critical functionality, even when security has been compromised ("fail-safe" modes); and

-- Providing methods for retention and recovery after an incident where security has been compromised.

  •  Hospital Networks/Health Care Facilities.  Hospital networks and health care facilities should evaluate their network security and take steps to protect the network. This includes:

--  Restricting unauthorized access to the network and networked medical devices;

-- Making certain appropriate antivirus software and firewalls are up-to-date;

-- Monitoring network activity for unauthorized use;

-- Protecting individual network components through routine and periodic evaluation, including updating security patches and disabling all unnecessary ports and services;

-- Contacting the specific device manufacturer if a cybersecurity problem related to a medical device is suspected; and

-- Developing and evaluating strategies to maintain critical functionality during adverse conditions.

Reed Smith will be issuing additional updates in the near future about these recent cybersecurity developments.

FDA Issues New Draft Guidance Documents on Access to Investigational Drugs

This post was written by Jennifer Pike.

On May 9, 2013, the Food and Drug Administration (“FDA”) announced the availability of two new draft guidance documents answering common questions on FDA’s implementation of regulations related to access to investigational drugs. The first draft guidance, entitled “Charging for Investigational Drugs Under an IND – Qs & As,” addresses FDA’s implementation of 21 C.F.R. § 312.8 and answers the most frequently-asked questions about charging for investigational new drugs under an investigational new drug (IND) Application (IND). The regulation, which went into effect in October 2009, clarifies the circumstances under which charging for an investigational new drug in a clinical trial is appropriate. It also sets forth criteria for charging for an investigations drug and clarifies what costs can be recovered for an investigational drug.

The second draft guidance, entitled “Expanded Access to Investigational Drugs for Treatment Use – Qs & As,” answers the most frequently-asked questions related to FDA’s implementation of its expanded access regulations (21 CFR Part 312, Subpart I). The regulations, which went into effect on October 2009, contain the requirements for the use of investigational new drugs or approved drugs where availability is limited by a risk evaluation and mitigation strategy, when the primary purpose is to diagnose, monitor, or treat a patient’s disease or condition.

Comments on the draft guidance documents should be submitted in writing, or electronically at www.regulations.gov, on or before July 8, 2013.

FDA Draft Guidance on Biosimilar Product Development Now Available

This post was written by Jennifer Pike.

A new draft guidance document on formal meetings between the FDA and biosimilar biological sponsors is now available from FDA. The draft guidance provides recommendations to industry on formal meetings between FDA and sponsors or applicants relating to the development and review of biosimilar biological products. Further, the draft guidance assists sponsors and applicants in generating and submitting meeting requests and the associated meeting package to FDA. The draft guidance provides good meeting management practices that are intended to provide consistent procedures that will promote well-managed meetings and ensure that such meetings are scheduled within a reasonable time, conducted efficiently, and documented appropriately. The following five meeting types are described in the draft guidance: (1) Biosimilar Initial Advisory meeting (initial assessment of whether licensure is feasible for product, and if so, general advice on development of product); (2) biosimilar biological product development (BPD) Type 1 meeting (meeting that is necessary for an otherwise stalled BPD program to proceed); (3) BPD Type 2 meeting (meeting to discuss a specific issue or questions where FDA will provide targeted advice); (4) BPD Type 3 meeting (in-depth data review and advice regarding on-going BPD program); and (5) BPD Type 4 meeting (meeting to discuss format and content of application). Comments on the draft guidance should be submitted in writing, or electronically at www.regulations.gov, by May 31, 2013. 

New FDA Draft Guidance Addresses Combination Product Postapproval Modification Submissions

This post was written by Jennifer Pike.

FDA has issued a new draft guidance document entitled “Submissions for Postapproval Modifications to a Combination Product Approved Under a BLA, NDA, or PMA.” The document provides guidance to industry and FDA staff on the underlying principles to determine the type of marketing submission that may be required for postapproval changes to a combination product that is approved under one marketing application (i.e., a biologics licensing application, a new drug application, or a premarket approval application). FDA regulations describe requirements related to postmarket submissions for changes to stand-alone products, but do not expressly address submissions for changes to combination products. The guidance intends to clarify and provide consistency with regard to the latter. Specifically, the document provides tables that may be helpful in determining what type of submission to use for a postmarket change to a constituent part of a combination product where the regulatory identity of the modified constituent part differs from the application type under which the combination product is approved. Comments on the draft guidance should be submitted, in writing or electronically, at www.regulations.gov by April 22, 2013.

FDA Issues Two New Draft Guidance Documents Related to the Conduct of Clinical Trials

This post was written by Jennifer Pike.

The Food and Drug Administration (FDA) recently issued two draft guidance documents related to the conduct of clinical trials. The first draft guidance, Draft Guidance for IRBs, Clinical Investigators and Sponsors: IRB Responsibilities for Reviewing the Qualifications of Investigators, Adequacy of Research Sites, and the Determination of Whether an IND/IDE Is Needed is intended to assist institutional review boards (IRBs), clinical investigators, and sponsors involved in clinical investigations of FDA-regulated products in determining whether the proposed research satisfies the criteria for IRB approval. Specifically, the guidance addresses the IRB’s role in reviewing: (1) the qualifications of investigators; (2) the adequacy of research sites; and (3) the determination of whether an investigational new drug (IND) application or investigational device exemption (IDE) is needed. Many of the recommendations in the guidance have appeared in other FDA guidance documents or have been communicated to IRBs who have contacted the agency directly about these issues, but FDA has compiled the information here to ensure that all IRBs are aware of and have access to it. When finalized, this guidance will supersede Question 56 in FDA’s January 1998 guidance Institutional Review Board Frequently Asked Questions – Information Sheet Guidance for Institutional Review Boards and Clinical Investigators.

The second draft guidance, Draft Guidance for Industry: Electronic Source Data in Clinical Investigations, provides guidance to sponsors, contract research organizations (CROs), data management centers, clinical investigators, and others involved in capturing, reviewing, and archiving electronic source data in FDA-regulated clinical investigations. This guidance revises and updates the draft guidance Electronic Source Documentation in Clinical Investigations. The draft guidance addresses source data (from clinical investigations) used to fill the predefined fields in an electronic case report form (eCRF), according to protocol , and discusses the following topics related to electronic source data: (1) identifying and specifying authorized source data originators; (2) creating data element identifiers to facilitate sponsors, FDA, and other authorized parties in examining the audit trail of data; (3) capturing source data into the eCRF using either manual or electronic capture methods; and (4) investigator responsibilities with respect to reviewing and retaining electronic data. Comments on both guidance documents will be accepted at www.regulations.gov until January 22, 2013.

New FDA Draft Guidance Documents Address Product Safety and Risk Minimization

This post was written by Jennifer Pike.

On December 13, 2012, the FDA issued two draft guidance documents related to product safety and risk minimization. The first guidance, Design Considerations for Devices Intended for Home Use, is intended to assist manufacturers in designing and developing home use medical devices that comply with applicable standards of safety and effectiveness and other regulatory requirements. The guidance identifies several factors that manufacturers should consider, especially during device design and development, and provides recommendations for reducing or minimizing these unique risks. Factors to consider in designing and developing medical devices for home use include the physical environment, the user, the device or system, the labeling, and the utilization of human factors. The guidance applies to both prescription and over-the-counter medical devices that are intended for home use. The second guidance, Safety Considerations for Product Design to Minimize Medication Errors, provides sponsors of IND applications, new drug applications, biologics licensing applications, abbreviated new drug applications, and nonprescription drugs marketed without an approved application with a set of principles for developing drug products using a systems approach to minimize medication errors relating to product design. The recommendations in the guidance are intended to improve the drug product and container closure design at the earliest stages of product development for all prescription and nonprescription drug products. This draft guidance is the first in a series of three planned guidance documents to minimize risks contributing to medication errors. Comments on both guidance documents should be submitted to www.regulations.gov by March 13, 2013.

FDA Meetings on Patient-Focused Drug Development Initiative

This post was written by Jennifer Pike.

On September 24, 2012, the Food and Drug Administration (FDA) published two notices in connection with its patient-focused drug development initiative. The first notice announces a public meeting and an opportunity for public comment related to the initiative, and the second notice requests that patient stakeholders notify FDA of their intention to participate in periodic consultation meetings on process issues related to the initiative. By way of background, under the Prescription Drug User Fee Act, FDA must meet standards related to enhanced patient representation in drug regulation decision-making. The patient-focused drug development initiative fulfills this requirement. Under this initiative, FDA will conduct public meetings to consider 20 different disease areas. The first of these meetings, at which FDA will provide an overview of the initiative, will be held on October 25, 2012. Attendees will be invited to comment on FDA’s preliminary list of nominated diseases for the initiative and the criteria used to develop the list. The registration deadline is October 18, 2012, and comments may be submitted by November 1, 2012.  In addition to public meetings to consider disease areas, FDA will hold meetings with patient stakeholders to discuss key process questions for patient-focused drug development. The deadline for stakeholders to notify FDA of their intention to participate is October 3, 2012, and the first meeting will be held on October 10, 2012.

Draft Guidance Regarding Self-Identification of Generic Drug Facilities and Q&A on Generic Drug User Fee Amendments

This post was written by Erin Janssen.

On August 27, 2012, FDA issued draft guidance documents for industry entitled "Self-Identification of Generic Drug Facilities, Sites, and Organizations" and "Generic Drug User Fee Amendments of 2012: Questions and Answers." The Generic Drug User Fee Amendments of 2012 (GDUFA) requires that generic drug facilities, sites, and organizations around the world provide identification information annually to FDA. The GDUFA also is designed to speed the delivery of safe and effective generic drugs to the public and reduce costs to industry, and enable FDA to assess user fees to support enhancements to FDA’s generic drugs program. The first draft guidance document is intended to assist industry as it prepares to meet the law’s self identification requirement. It explains who is required to self-identify, what information must be requested, how the information should be submitted to FDA, and what the penalty is for failure to self-identify. The second guidance document answers common questions from the generic drug industry and other interested parties involved in the development and/or testing of generic drug products regarding the requirements and commitments of GDUFA. To be considered before FDA begins work on the final versions of these documents, comments should be submitted by October 26, 2012.

FDA Guidance on FY 2013 Medical Device User Fee Small Business Qualification and Certification

This post was written by Erin Janssen.

The FDA has issued guidance on FY 2013 medical device user fees for small businesses. The guidance explains how a business may qualify as a “small business” and pay most FY 2013 medical device user fees at substantially discounted rates. While the guidance is substantively the same as the guidance provided for FY 2012, the following new considerations are particularly significant:

  • The guidance explains that there is no small business discount for the establishment registration fee. If this is the only fee a business expects to pay during FY 2013, it should not submit an FY 2013 Small Business Qualification Certification.
  • A foreign business may qualify as a small business, even if it has not submitted a federal (U.S.) income tax return.

As of September 30, this document supersedes “Guidance for Industry, FDA, and Foreign Governments: FY 2012 Medical Device User Fee Small Business Qualification and Certification,” as issued on May 25, 2012.

FDA Issues Guidance for Comment on Refuse to Accept Policy for 510(k)s

This post was written by Erin Janssen.

On August 13, 2012, FDA released draft guidance for public comment entitled “Refuse to Accept Policy for 510(k)s.” The purpose of this document is to explain the procedures and criteria FDA intends to use in determining whether a premarket notification (510(k)) submission is administratively complete, which determines whether it should be accepted for substantive review. The guidance is applicable to 510(k)s reviewed by the Center for Devices and Radiological Health and the Center for Biologics Evaluation and Research. To ensure that comments are considered before the agency begins work on the final version of the guidance, interested parties should submit comments on the draft guidance by September 27, 2012.

FDA Issues Draft Guidance Regarding Acceptance & Filing Review for PMA Applications

This post was written by Erin Janssen.

FDA has announced the release of a draft guidance document concerning the necessary elements and contents of a complete premarket approval (PMA) application and the key decisions that are made during the filing process. The draft guidance applies to all devices reviewed in a PMA application and, if accepted as final, will replace FDA's original 2003 PMA guidance review criteria and checklist. The draft guidance is intended to enhance the consistency of acceptance and filing decisions and to help applicants better understand the types of information FDA needs to conduct a substantive review of a PMA. Unlike FDA's original 2003 guidance on PMA reviews, the new draft guidance separates the criteria review for PMA filings into two areas: (1) acceptance criteria, and (2) filing criteria. During an acceptance criteria review, the draft guidance states that FDA will review the completeness of the application and inform the applicant in a written response within the first 15 calendar days of receipt of the application whether any elements are missing, and if so, identify the missing elements. Comments on the draft guidance should be submitted to the FDA by September 14, 2012.

FDA Draft Guidance the Medical Device Pre-Submission Program/Meetings with FDA Staff

This post was written by Erin Janssen.

On July 13, 2012, FDA issued draft guidance entitled "Medical Devices: The Pre-submission Program and Meetings with FDA Staff." The new draft guidance outlines recommendations for sponsors and FDA staff and managers as well as expected timeframes for scheduling meetings. In addition, the guidance describes the procedures that CDRH and CBER intend to follow when manufacturers, their representatives, or application sponsors request a meeting with review staff, either as the preferred method of feedback in response to a pre-submission request, or to discuss to an existing regulatory submission. Finally, the guidance recommends how to prepare for meetings with FDA staff. When final, the new guidance document will supersede 1999 guidance entitled “Pre-IDE Program: Issues and Answers - Blue Book Memo D99-1.” Although comments may be submitted on any guidance at any time, interested parties should submit comments on the draft guidance by October 11, 2012. 

FDA Small Entity Compliance Guidance: Toll Free Number Labeling for Drugs

This post was written by Erin Janssen.

The FDA has published a Small Entity Compliance Guide entitled "Toll-Free Number Labeling and Related Requirements for Over-the-Counter and Prescription Drugs Marketed With Approved Applications." This guidance is intended to help small businesses understand and comply with the requirements of the October 28, 2008 final rule on labeling of drugs with a toll-free number for adverse event reporting. The guidance describes certain requirements of the final rule in plain language and provides answers to common questions on how to comply with the rule.

FDA Draft Guidances Describe Product-Specific Bioequivalence Recommendations

This post was written by Erin Janssen.

The FDA has released additional draft and revised draft product-specific bioequivalence (BE) recommendations. The recommendations provide product specific guidance on the design of BE studies to support abbreviated new drug applications (ANDAs). The new BE recommendations were developed using the process described by FDA in a June 11, 2010 notice. The public is encouraged to submit comments on the new recommendations by August 13, 2012. 

Older Entries

July 16, 2012 — FDA Draft Guidance Document on Transferring Clinical Investigation Oversight to Another IRB

July 16, 2012 — FDA Guidance Addresses Genotoxicity Testing and Data Interpretation for Human Drugs

May 11, 2012 — FDA Guidance on Medical Device Pre-market Approval

May 11, 2012 — FDA Seeks Information on Risks, Benefits of Metal-on-Metal (MoM) Hip Replacements

May 11, 2012 — FDA Reports on Post-Approval Drug Safety Monitoring

May 11, 2012 — International Collaboration Highlighted in FDA Global Engagement Report

March 30, 2012 — FDA Announces Delayed Enforcement of ACA Drug Sample Distribution Reporting Requirement

March 29, 2012 — FDA Draft Guidance on Classifying Significant Postmarket Drug Safety Issues

March 29, 2012 — FDA Issues Guidance Update on Communication to the Public about Drug Safety

March 29, 2012 — Draft FDA Guidance Targets Direct-to-Consumer Television Marketing

March 14, 2012 — FDA Issues Three Draft Guidance Documents on Biosimilar Product Development; Announces May 11 Public Hearing

March 14, 2012 — FDA Draft Guidance on Safety Data Collection for Late Stage Premarket & Postmarket Investigations

February 13, 2012 — FDA Issues Guidance on New Informed Consent Requirements

February 10, 2012 — FDA and Industry Reach Agreement in Principle on Medical Device User Fees

February 10, 2012 — FDA Q&A/Draft Guidance for Industry Related to PET Drug Products

February 10, 2012 — FDA Report on Exploratory Program to Increase Access to Agency Compliance and Enforcement Data

January 25, 2012 — FDA Completes Work on Three Drug User Fee Programs

January 25, 2012 — FDA Guidance on Product Name Placement in Advertising and Promotional Labeling

December 29, 2011 — FDA Guidance Regarding Responding to Unsolicited Requests for Off-Label Information

December 29, 2011 — FDA Issues Draft Guidance Regarding Evaluation of Sex Differences in Medical Device Clinical Studies

December 29, 2011 — FDA Provides Draft Guidance on Evaluating Substantial Equivalence in Premarket Notifications

December 29, 2011 — FDA Guidance Regarding CDRH Appeals Process

December 13, 2011 — FDA Draft Guidance on Artificial Pancreas Device Systems, Hepatitis B Screening of Blood/Blood Components

December 12, 2011 — FDA Public Meeting on Generic Drug User Fees (Dec. 19)

November 10, 2011 — President Issues Executive Order Regarding Drug Shortages

October 14, 2011 — FDA Issues Final Guidance on Risk Labeling for Prescription Drugs and Biological Products

October 14, 2011 — FDA Issues Draft Guidance to Clarify De Novo Classification Process

October 14, 2011 — FDA Seeks Comments on Proposal to Increase Transparency

September 26, 2011 — Draft FDA Guidance on Exculpatory Language in Informed Consent

September 26, 2011 — FDA Guidance on Reproductive and Developmental Toxicities

September 1, 2011 — FDA Issues Strategic Plan for Regulatory Science

September 1, 2011 — FDA Issues Draft Guidance Proposing Risk Based Approach to Oversight of Clinical Investigations

August 16, 2011 — FDA Issues Draft Guidance Regarding Design of Pivotal Clinical Investigations for Medical Devices

August 16, 2011 — FDA Issues Guidance for Small Businesses on cGMP for Positron Emission Tomography (PET) Drugs

July 28, 2011 — FDA Issues Draft Guidance Regarding When to Submit a 510(k) for a Change to an Existing Device; Guidance Follows 510(k) Working Group Recommendations

July 26, 2011 — FDA Issues Draft Guidance Regarding Mobile Medical Applications

July 26, 2011 — FDA Issues Guidance and Final Rule Regarding Focused Ultrasound Stimulators for Aesthetic Use

April 29, 2011 — FDA Final Guidance Documents on Writing Requests for Product Designation

April 29, 2011 — FDA Issues Guidance on Manufacturing Method/Process Changes

March 7, 2011 — FDA Draft Guidance Documents: Electronic Data Sets for Pharmacoepidemiologic Studies, Pharmacogenomics/Premarketing Evaluation, REMS Medication Guides

February 10, 2011 — FDA Launches Medical Device Initiative to Reform the 510(k) Process, Meeting Scheduled to Receive Feedback

February 10, 2011 — FDA Releases Guidance Document on Process Validation

January 27, 2011 — FDA Announces Plans to Reform 510(k) Process

January 13, 2011 — FDA Draft Guidance on Electronic Source Documents in Clinical Trials

January 13, 2011 — FDA Report on Agency Transparency with Regulated Industry

January 13, 2011 — FDA Draft Guidance on Co-Development of Novel Combination Drugs

December 15, 2010 — FDA Seeks Stakeholder Participation in ACA Biosimilars User Fee Meetings

December 15, 2010 — FDA Issues Guidance on Public Input Portion of Advisory Committee Meetings

November 15, 2010 — FDA Issues Second Annual Report on Sponsor Compliance with Postmarketing Requirements

October 28, 2010 — FDA Seeks Comments on Draft Guidance Concerning Drug Development Tools

October 28, 2010 — FDA Seeks Comments on Draft Guidance Addressing Human Clinical Studies that Do Not Require an IND

September 30, 2010 — FDA Seeks Comment on Study Regarding Influence of DTC Promotional Offers on Consumer Perception

September 17, 2010 — FDA Draft Guidance on Occurrence of Suicidality in Clinical Trials

August 13, 2010 — Memorandum of Understanding Between FDA and CMS

August 13, 2010 — FDA Meeting and Request for Comments on Generic Drug User Fee Program

August 13, 2010 — FDA Announces Medical Device User Fees for FY 2011, Upcoming Meeting (Sept. 12)

August 13, 2010 — FDA Proposes Changes to the 510(k) Program; Seeks Public Comment

August 13, 2010 — FDA Guidance on Label Comprehension Studies for Over-the-Counter (OTC) Drugs

August 13, 2010 — Guidance on Whether Radioactive Studies Require an Investigational New Drug (IND) Application

August 13, 2010 — FDA Withdraws Direct Final Rule Requiring the Submission of Information on Pediatric Uses of Devices

August 13, 2010 — CDRH Announces 2010 Compliance Strategic Plan

July 7, 2010 — FDA Seeks Comments on Draft Guidance on Changes to CMC Reportable Information

July 7, 2010 — FDA Guidance on Frequently-Asked Questions for In Vitro Diagnostic Studies

June 18, 2010 — FDA Oversight of Laboratory Developed Tests (LDTs): Meeting and Comment Period

June 18, 2010 — FDA Guidance on Bioequivalence Study Design for Specific Products

June 18, 2010 — FDA Seeks Comment on Co-development of Two or More Investigational Drugs

June 18, 2010 — FDA Requests Notices of Intent to Participate in Periodic PDUFA Reauthorization Meetings

June 18, 2010 — FDA's CDER Requests Comments on Plan for Development of Data Standards

June 18, 2010 — FDA Meeting on Risk Evaluation and Mitigation Strategies (July 27-28)

June 18, 2010 — FDA and FCC Join for Public Meeting on Integration and Use of Wireless Technology with Health Care Devices (July 26-27)

June 18, 2010 — FDA to Post New On-line Information Regarding Safety Monitoring Issues for Recently-Approved Drugs and Biologics

May 25, 2010 — FDA Guidance on Medical Device Voluntary Audit Report Submission Program

May 25, 2010 — FDA Seeks Comment on Transparency Proposals

May 25, 2010 — FDA and NIH Launch Safety Reporting Website

May 13, 2010 — FDA Launches "Bad Ad" Initiative

May 13, 2010 — FDA Experimental Study of Patient Information Prototypes

May 13, 2010 — FDA Guidance on Enforcement of Regulations Restricting Sale and Distribution of Cigarettes & Smokeless Tobacco

April 30, 2010 — FDA Draft Guidance on Financial Information for Advisory Committee Members

April 30, 2010 — FDA Announces New Procedures for CDRH Advisory Committees

April 30, 2010 — FDA Draft Guidance on 513(g) Requests for Medical Devices

April 29, 2010 — FDA Confirms Focus on Enforcement and Initiative to Bring Criminal Prosecutions of Company Executives

March 31, 2010 — FDA Realignment of the Office of New Drugs within CDER

March 31, 2010 — FDA Issues Guidance Document on Drug Pedigree Issues

March 31, 2010 — FDA Guidance on Content and Format of the Dosage and Administration Section of Labeling

March 15, 2010 — FDA Requests Comments on Increasing Transparency in the Agency

March 15, 2010 — FDA Guidance Intended to Bolster Vaccine Development

March 15, 2010 — ICH Guidance on Non-Clinical Studies on Anti-Cancer Pharmaceuticals

March 15, 2010 — FDA Draft Guidance on Non-Inferiority Clinical Trials

March 15, 2010 — FDA Draft Guidance on Adaptive Design Clinical Trials for Drugs and Biologics

February 26, 2010 — FDA And NIH Announce Collaboration to Speed Patient Access to New Therapies

February 26, 2010 — FDA Listing of Drugs with Potential Safety Issues

February 12, 2010 — Draft Guidance on Continuing IRB Review after Clinical Investigation Approval

February 12, 2010 — Draft Guidance on Assessment of Abuse Potential of Drugs

February 12, 2010 — Use of Bayesian Statistics in Medical Device Clinical Trials

February 12, 2010 — Nonclinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization for Pharmaceuticals

February 12, 2010 — Guidance on Complete Submissions for the Evaluation of Proprietary Names

February 12, 2010 — FDA Initiative to Reduce Unnecessary Radiation Exposure from Medical Imaging

January 13, 2010 — FDA Guidance Document: Planning for the Effects of High Absenteeism to Ensure Availability of Medically Necessary Drug Products

December 21, 2009 — FDA Guidance on Use of Patient-Reported Outcome Measures to Support Labeling Claims

December 4, 2009 — FDA Announces Safe Use Initiative for Drug Products