FDA Issues Three Biosimilar Final Guidances

This post was written by Vicki Morris and Jennifer Pike.

On April 28, 2015, the federal Food and Drug Administration (FDA) finalized three guidances for industry on developing biosimilar drugs. The guidances, which follow the FDA’s first approval of a biosimilar drug in March, are intended to clarify both scientific and regulatory considerations for a broad range of stakeholders, including drug companies, in manufacturing biosimilars. The guidances include: Scientific Considerations in Demonstrating Biosimilarity to a Reference Product; Quality Considerations in Demonstrating Biosimilarity of a Therapeutic Protein Product to a Reference Product; and Biosimilars: Questions and Answers Regarding Implementation of the Biologics Price Competition and Innovation Act of 2009.

Scientific Considerations

The guidance on scientific considerations provides an overview of FDA’s approach to determining biosimilarity. Specifically, this guidance purports to assist sponsors in demonstrating that a proposed therapeutic protein product is biosimilar to a reference product for the purpose of submitting a marketing application through an abbreviated licensure pathway under section 351(k) of the Public Health Service Act. Under the guidance, FDA highlights the Agency’s intention to consider the totality of the evidence submitted in a 351(k) application. FDA also notes the importance of particular scientific considerations in demonstrating biosimilarity, including a stepwise approach to demonstrating biosimilarity and general scientific principles in conducting comparative structural analyses, functional assays, animal testing, human pharmacokinetics and pharmacodynamics studies, clinical immunogenicity assessment, and comparative clinical trials, including clinical study design issues.

Quality Considerations

The guidance on quality considerations provides sponsors with an overview of analytical factors that are relevant to assessing whether a proposed biosimilar product (i.e., a therapeutic protein product) and the reference product are highly similar for the purpose of submitting a marketing application through the 351(k) abbreviated licensure pathway. By way of background, biosimilarity is defined to mean that the biological product is highly similar to the reference product notwithstanding minor differences in clinically inactive components and that there are no clinically meaningful differences between the biological product and the reference product in terms of the safety, purity, and potency of the product. In making this highly similar determination, FDA deemed the following factors important: expression system, manufacturing process, assessment of physiochemical properties, functional activities, receptor binding and immunochemical properties, impurities, reference product and reference standards, finished drug product, and stability.

Questions and Answers

Lastly, FDA issued answers to common questions from sponsors interested in developing proposed biosimilar products, biologic license application (BLA) holders, and other interested parties regarding FDA’s interpretations of the Biologics Price Competition and Innovation Act of 2009, which created the abbreviated licensure pathway for biosimilar products. The Q&A’s cover biosimilarity vs. interchangeability, provisions related to requirement to submit a BLA for a “biological product,” and exclusivity. FDA also noted that an alternative approach may be used if such approach satisfies the requirements of the applicable statutes and regulations.

FDA Draft Guidance on Acceptance of Medical Device Clinical Data from Studies Conducted Abroad

As discussed on our Life Sciences Legal Update blog, the FDA has released draft guidance clarifying its acceptance of medical device clinical data from studies conducted outside of the United States. The draft guidance highlights special considerations that apply when using foreign clinical data, including applicability to populations within the US, and provides recommendations to assist sponsors in ensuring their data are adequate under applicable FDA standards.  Comments on the guidance are due by July 20, 2015.

CMS, FDA Establishing Interagency Task Force on LDT Quality Oversight

CMS and FDA are establishing an interagency task force to reinforce their collaboration regarding the oversight of laboratory-developed tests (LDTs), which are tests intended for clinical use and designed, manufactured, and used within a single lab. According to an FDA blog post, the goals of the FDA/CMS task force include: (1) identifying areas of similarity between the FDA quality system regulation and requirements under the Clinical Laboratory Improvement Amendments (CLIA); (2) working together to clarify responsibilities for laboratories that fall under the purview of both agencies; and (3) leveraging joint resources to avoid duplication and maximize efficiencies.

FDA to Host Clinical Outcome Assessments Public Workshop (April 1)

On April 1, 2015, the FDA is hosting a workshop entitled “Clinical Outcomes Assessment Development and Implementation: Opportunities and Challenges.” The workshop will update the public on ongoing efforts in the use of clinical outcome assessments (COAs), and plan for the future of COA development and utilization in drug development programs. The workshop will also discuss how to incorporate patient-centered outcome measures, standards for COA use, and collaborative processes for COA development and dissemination.  Interested parties may participate in person or via webcast. The registration deadline is March 27, 2015.

Happy New Year! FDA Helps Industry Ring in New Year with Generous DSCSA Compliance Policy

This post was written by Kevin M. Madagan.

Time to pop the bubbly a little early! FDA announced today that the Drug Supply Chain Security Act (DSCSA) deadline of January 1, 2015 for product tracing (i.e., the new federal pedigree standards) will not be enforced until May 1, 2015. This means manufacturers, wholesale distributors, and repackagers have an additional four months to work with trading partners to determine how best to comply with the DSCSA pedigree standards.  Although we are not surprised by this development, it is still cause to celebrate, given the potential adverse impact of enforcing the requirements before industry is prepared for compliance.

The new DSCSA Compliance Policy – DSCSA Implementation: Product Tracing Requirements – Compliance Policy Guidance for Industry – announces that FDA “recognizes” that some manufacturers, wholesale distributors, and repackagers “may need additional time to work with trading partners” to ensure that all of the product tracing information required under the DSCSA is provided to and captured by the recipient trading partner. It also acknowledges the very real concern that enforcing the January 1, 2015 deadline could disrupt the supply chain and impact patients’ access to needed prescription drugs. 

The DSCSA Compliance Policy is clear: FDA “does not intend to take action against trading partners (manufacturers, wholesale distributors, and repackagers) who do not, prior to May 1, 2015, provide or capture the transaction information, transaction history, and transaction statement required by section 582 of the FD&C Act (product tracing information) associated with each transaction of certain human, finished prescription drugs, as defined in section 581 of the FD&C Act (21 U.S.C. 360eee).” The policy is limited only to the DSCSA requirements that trading partners provide and capture product tracing information; it does not extend to other DSCSA requirements, such as verification related to suspect and illegitimate product (including quarantine, investigation, notification and recordkeeping) and requirements related to engaging in transactions only with authorized trading partners.

FDA Releases Two Draft Guidance Documents on Proposed Laboratory Developed Test (LDT) Regulatory Oversight

This post was written by Jennifer Pike and Vicki Morris.

On September 30, 2014, the Food and Drug Administration (FDA) announced the availability of two draft guidances intended to implement a new regulatory oversight framework for LDTs, which are defined by the FDA as "a type of in vitro diagnostic test that is designed, manufactured and used within a single laboratory" and which are intended for clinical use. Release of the documents follows on the heels of FDA’s notification to Congress in late July of its intent to issue draft guidance in this area. The first draft guidance, "Framework for Regulatory Oversight of Laboratory Developed Tests (LDTs)" (Framework Guidance), describes a risk-based framework for addressing the regulatory oversight of LDTs. The Framework Guidance also describes FDA’s priorities for enforcing pre- and post-market requirements for LDTs, and the process by which FDA intends to phase in enforcement of FDA regulatory requirements for LDTs over time. The second draft guidance, "FDA Notification and Medical Device Reporting for Laboratory Developed Tests (LDTs)" (Notification and Reporting Guidance), describes the process for clinical laboratories to notify FDA of the LDTs they manufacture as well as the Medical Device Reporting (MDR) requirements for clinical laboratories that manufacture LDTs. Both draft guidances reflect the FDA’s effort to take steps to encourage the advancement of personalized medicine by helping to ensure the reliability of certain diagnostic tests. The guidances are neither final nor in effect at this time.  

The following is an overview of the specific issues addressed in the draft guidances:

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FDA Releases "Purple Book," Including Biosimilar Products

The FDA’s new “Purple Book” lists biological products licensed by FDA under the Public Health Service Act (the PHS Act). The publication includes information on whether FDA evaluated the biological product for reference product exclusivity under section 351(k)(7) of the PHS Act, and whether the FDA has determined a biological product to be biosimilar to or interchangeable with a reference biological product.

FDA Releases Final Medical Device Cybersecurity Guidance, Schedules Workshop on Topic

Yesterday the FDA issued final guidance entitled “Content of Premarket Submissions for Management of Cybersecurity in Medical Devices,” which includes recommendations for medical device manufacturers on cybersecurity management and information that should be included in a pre-market submission. The recommendations are intended to supplement previous FDA guidances, “Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices,” and “Guidance to Industry: Cybersecurity for Networked Medical Devices Containing Off-the-Shelf (OTS) Software.”

In a related development, on October 21-22, 2014, the FDA is holding a public workshop on “Collaborative Approaches for Medical Device and Healthcare Cybersecurity.” Through the workshop, FDA seeks to encourage collaboration among stakeholders, identify challenges, and discuss strategies and best practices for promoting medical device cybersecurity.

FDA Seeks Comments to Updated Guidance on Informed Consent in Clinical Trials

This post was written by Jennifer Pike and Vicki Morris.

Earlier this summer, the Food and Drug Administration (FDA) issued a draft 42-page "Informed Consent Information Sheet" that provides guidance for institutional review boards (IRBs), clinical investigators, and clinical trial sponsors on complying with the Agency’s informed consent regulations. Once finalized, the draft guidance will supersede FDA’s previous Information Sheet on this topic, "A Guide to Informed Consent," which was last updated over 15 years ago, in 1998.  The guidance, which is a compilation of FDA’s regulations and past guidances on informed consent, also reflects the Agency’s coordinated efforts with the Department of Health and Human Services (HHS) to facilitate consistency across informed consent requirements and policies among federal government agencies.

Broadly, the new guidance indicates FDA policy shifting towards enhanced informed consent processes. More narrowly, the draft guidance explains the various and often caveated elements of informed consent (including providing patients with a description of the trial, its risks, benefits, alternative treatments, confidentiality and compensation in the event of injury), depicts the detailed responsibilities of IRBs, clinical investigators and sponsors of clinical trials (including compliance with the process, elements and documentation of informed consent), and provides examples of recommended language to assist industry parties in complying with FDA’s informed consent regulations. FDA accomplishes this task by clarifying some aspects of existing guidance and creating additional guidance in new areas.

The following provides an overview of some of the draft guidance’s notable new and revised provisions.

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FDA Meeting on Biomarker Development (Sept. 5)

On September 5, 2014, the FDA is holding a public meeting at the Washington Plaza Hotel, in Washington DC, to discuss current scientific and regulatory approaches to biomarker development, acceptance, and utility in the development of therapeutic products (e.g., drugs and biologics). Specifically, FDA will focus on (1) identifying challenges for biomarker applications in early- and late- phase clinical trials, and (2) emerging best practices for successful biomarker-based programs (including codevelopment of in vitro diagnostic devices and use of biomarkers as outcome measures in clinical trials). Public input from the meeting will be used to identify opportunities for biomarker-related regulatory guidance, improve understanding and consistency in regulatory review of therapeutic product applications that incorporate biomarkers in clinical trial designs, and identify potential strategies to facilitate scientific exchanges in regulatory and non-regulatory contexts. For more information on the meeting, which is being held in collaboration with Brookings Institution, and for early registration deadlines to attend the live meeting, see the FDA announcement.  FDA will also accept comments on this topic through November 5, 2014.

FDA Will Not Enforce Compliance for Mobile Device Data Systems and Other Low Risk Devices, Agency Reports

This post was written by Jennifer Pike.

In a new draft guidance document, the Food and Drug Administration (FDA) has announced that it does not intend to enforce compliance with general regulatory controls that apply to Medical Device Data Systems (MDDS), medical image storage devices and medical image communications devices.

MDDS refers to hardware and software that transfers, stores, converts format and displays medical device data, but that does not modify the data or control the functions or parameters of any connected medical device. In 2011, MDDS were classified by FDA as Class I medical devices subject to general regulatory controls under the Federal Food, Drug and Cosmetic Act. FDA has since determined that MDDS pose a low risk to the public and play an important role in advancing health.  The agency has therefore decided not to enforce compliance with the controls that apply to MDDS, medical image storage devices and medical image communications devices (e.g., registration and listing, premarket review, postmarket reporting and quality system regulation).

The draft guidance also proposes changes to FDA’s draft guidance titled “Mobile Medical Applications” issued on September 25, 2013 to conform with the new draft guidance.

Comments regarding the draft guidance should be submitted to FDA by August 25, 2014.

FDA Releases Drug/Device Industry Social Media Guidance Documents

The FDA released two draft social media guidance documents last week, describing how manufacturers, packers and distributors of prescription drugs and medical devices may: (1) communicate both benefit and risk information on Internet/social media platforms with character space limitations, and (2) correct independent third-party misinformation about a firm’s products.  For details, see Reed Smith's Client Alert posted on our Life Sciences Legal Update blog.

FDA Issues Draft Guidance on Communicating New Risk Information about an Approved Drug Product - Comment Opportunity

This post was written by Jillian W. Riley.

On June 6, 2014, the US Food and Drug Administration (FDA) issued a draft guidance addressing the distribution of new risk information to health care providers (HCPs) and health care entities (HCEs). The draft guidance defines “new risk information” as “information that becomes available after a drug is marketed that rebuts or mitigates information about a risk already identified in the approved labeling or otherwise refines risk information in the approved labeling in a way that does not indicate great seriousness of the risk.” The draft guidance is not intended to address risk information that is newly identified, but that which was not available at the time FDA approved the labeling. Acknowledging the evolving nature of a drug’s safety profile, the draft guidance is aimed at helping sponsors better communicate “new risk information” in order to allow HCPs and HCEs make the best decision for each patient.

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FDA Initiative Opens Door to Easily Accessible, User-Friendly Data

This post was written by Jennifer Pike.

Yesterday, the U.S. Food and Drug Administration (FDA) made available data on millions of reports of drug adverse events and medication errors made to FDA between 2004 and 2013. The release of the data is part of FDA’s new data sharing initiative, openFDA, which is designed to make it easier for developers, researchers and the public to access data collected by FDA. OpenFDA organizes large amounts of publicly-available data in a structured, computer-readable format and makes it possible for users to instantaneously search and pull the data for their own use. . According to Walter Harris, FDA’s chief operating officer and acting chief information officer, “openFDA is a valuable resource that will help those in the private and public sectors use FDA public data to spur innovation, advance academic research, educate the public, and protect public health.”

For now, openFDA will begin as a pilot program with data involving the drug adverse event and medication error reports. FDA will later expand openFDA to include data on product recalls and product labeling.

Expedited Drug Development and Review: New FDA Resource Now Available

This post was written by Jennifer Pike.

A new guidance entitled “Expedited Programs for Serious Conditions – Drugs and Biologics” is now available from the Food and Drug Administration (FDA). The 40-page guidance is intended to serve as a single resource for information on FDA’s policies and procedures related to its four expedited drug development and review programs: (1) fast track designation, (2) breakthrough therapy designation, (3) accelerated approval, and (4) priority review designation. The guidance also defines the threshold criteria generally applicable to each program, including when a condition is considered “serious,” when a therapy is “available therapy,” and when a medical need is “unmet.”   The guidance follows the 2012 passage of the Food and Drug Administration Safety and Innovation Act, which called for FDA to expand its efforts to expedite the development and review of drugs intended to treat serious conditions.  Comments regarding the guidance may be submitted at any time.

FDA Workshop to Focus on 3-D Printing of Medical Devices

According to the Food and Drug Administration (FDA), additive manufacturing, also known as 3-D printing, is entering mainstream use in medical devices, both as an alternative device production method for traditional components and as a method to create patient-matched devices. FDA has begun to receive submissions using additive manufacturing for medical devices, and the agency sees “many more on the horizon.” As the use of additive manufacturing becomes more widespread, the FDA wants additional information on scientific and technical challenges associated with the use of such technology for medical devices, particularly with regard to process verification and validation to ensure patient safety. To that end, the FDA is hosting a public workshop on October 8 and 9, 2014 entitled “Additive Manufacturing of Medical Devices: An Interactive Discussion on the Technical Considerations of 3-D Printing.'' The meeting is intended to provide a forum for FDA, medical device manufactures, additive manufacturing companies, and academia to explore this issue in detail, including ways to provide a transparent evaluation process for future submissions. The workshop discussion may facilitate development of new draft guidances and/or standards for additive manufacturing of medical devices. Comments on the workshop topic will be accepted until November 10, 2014.

Busy Week for FDA's Center for Devices and Radiological Health

This post was written by Jillian W. Riley

Earlier this week, FDA’s Center for Devices and Radiological Health (CDRH) published two separate draft guidance documents to advance the dual goals of FDA and industry to provide pathways for medical devices to reach the market quickly while ensuring the safety and efficacy of the product.

The first guidance, entitled Balancing Premarket and Postmarket Data Collection for Devices Subject to Premarket Approval, clarifies FDA’s current thinking on creating an effective means to achieve “the right balance of premarket and postmarket data collection facilitates timely access to important new technology without undermining patient safety.” Greater reliance on postmarket data collection can help a new product reach the market – and patients – sooner. One key factor FDA considers when determining whether postmarket data collection is appropriate is the device’s potential impact on public health. For example, and as discussed more thoroughly in the separate guidance discussed below, FDA may accept greater pre-approval uncertainty regarding specific benefits and risks of devices where there is demonstrated potential to address unmet medical needs.

The second guidance, Expedited Access for Premarket Approval Medical Devices Intended for Unmet Medical Need for Life Threatening or Irreversibly Debilitating Diseases or Conditions, proposes a new expedited review program for medical devices that address unmet medical needs and are subject to premarket approval (PMA) applications. The program laid out in the draft guidance establishes opportunities for earlier and more active engagement between sponsors and FDA staff, including earlier involvement of senior management to ensure more consistency in messaging to industry. The early interactions aim to establish better plans for efficient collection of the scientific and clinical data necessary to support FDA’s approval determinations. The guidance also describes the criteria an applicant must meet in order to obtain an expedited access PMA designation.

FDA will be accepting comments regarding the draft guidances until July 23, 2014.

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.

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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.

Older Entries

January 20, 2014 — FDA Seeks Comments on Drug Company Social Media Guidance

January 7, 2014 — FDA Releases Final Guidance on Qualification Process for Drug Development Tools

August 2, 2013 — New Draft Guidances from FDA Address Expedited Review, Safety Labeling and More

June 20, 2013 — Draft FDA Guidance Recommends Cybersecurity Risk Assessments and Management Plans for Premarket Medical Device Submissions

May 28, 2013 — FDA Issues New Draft Guidance Documents on Access to Investigational Drugs

April 15, 2013 — FDA Draft Guidance on Biosimilar Product Development Now Available

January 29, 2013 — New FDA Draft Guidance Addresses Combination Product Postapproval Modification Submissions

December 18, 2012 — FDA Issues Two New Draft Guidance Documents Related to the Conduct of Clinical Trials

December 18, 2012 — New FDA Draft Guidance Documents Address Product Safety and Risk Minimization

September 27, 2012 — FDA Meetings on Patient-Focused Drug Development Initiative

September 6, 2012 — Draft Guidance Regarding Self-Identification of Generic Drug Facilities and Q&A on Generic Drug User Fee Amendments

September 5, 2012 — FDA Guidance on FY 2013 Medical Device User Fee Small Business Qualification and Certification

September 5, 2012 — FDA Issues Guidance for Comment on Refuse to Accept Policy for 510(k)s

July 31, 2012 — FDA Issues Draft Guidance Regarding Acceptance & Filing Review for PMA Applications

July 16, 2012 — FDA Draft Guidance the Medical Device Pre-Submission Program/Meetings with FDA Staff

July 16, 2012 — FDA Small Entity Compliance Guidance: Toll Free Number Labeling for Drugs

July 16, 2012 — FDA Draft Guidances Describe Product-Specific Bioequivalence Recommendations

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