Tag Archives: Food & Drug Administration Developments

FDA Issues Final Guidance Documents on Drug and Medical Device Submissions

On January 2, 2013, the FDA issued three final guidance documents related to drug and medical device submissions. The first guidance, Acceptance and Filing Reviews for Premarket Approval Applications, is intended to clarify the criteria for accepting and filing a premarket approval application (PMA) to assure the consistency of FDA’s acceptance and filing decisions. The … Continue Reading

FDA Releases Draft Guidance Documents on Providing Submissions in Electronic Format

The FDA released draft guidance on January 3, 2013 entitled Providing Regulatory Submissions in Electronic Format – Certain Human Pharmaceutical Product Applications and Related Submissions Using eCTD Specifications. The guidance is being issued in accordance with the Food and Drug Administration Safety and Innovation Act, which amended to Federal Food, Drug, and Cosmetic Act to … Continue Reading

FDA Draft Guidance Addresses Clinical Trial Enrichment

The FDA is seeking comments on draft guidance related to clinical trial enrichment: Enrichment Strategies for Clinical Trials to Support Approval of Human Drugs and Biological Products. The document is designed to provide guidance to industry on enrichment strategies that can be used in clinical trials intended so support effectiveness and safety claims in NDAs … Continue Reading

FDA Issues Two Final Guidances on Safety Reporting Requirements

The FDA has released two final guidance documents intended to help sponsors and investigators comply with safety reporting requirements for IND applications and bioavailability (BA) and bioequivalence (BE) studies: Safety Reporting Requirements for INDs and BA/BE Studies, and Safety Reporting Requirements for INDs and BA/BE Studies – Small Entity Compliance Guide. Comments regarding both guidance … Continue Reading

FDA To Hold Workshop on Accessible Standardized Medical Device Labeling (April 29-30)

On April 29 and 30, 2013, the Food and Drug Administration (FDA) is hosting a public workshop on “Accessible Standardized Medical Device Labeling."  The purpose of the event is to discuss the need for medical device labeling to be delivered in a clear, concise, and readily accessible format so that patients, caregivers, and healthcare providers … Continue Reading

FDA Addresses Food and Drug Administration Safety and Innovation Act (FDASIA) Implementation

On November 19, 2012, the Food and Drug Administration (FDA) published a notice and an amendment to a proposed rule related to FDA’s implementation of the FDASIA, which was signed into law on July 9, 2012. In the notice, FDA announced that it is seeking information from all stakeholders (including patients, physicians, dentists, and manufacturers) … Continue Reading

Upcoming FDA Public Meeting: Framework for Pharmacy Compounding/State and Federal Roles (Dec. 19)

On December 19, 2012, the FDA is hosting a public meeting entitled “Framework for Pharmacy Compounding: State and Federal Roles” (the meeting also will be webcast). While the FDA acknowledges that “the States play a critical role in the oversight of traditional pharmacy compounding,” the FDA observes that “a category of “non-traditional” compounding has evolved … Continue Reading

FDA Issues Generic Drug User/Backlog Fee Notices

On October 25, 2012, the Food and Drug Administration (FDA) published in the Federal Register the fiscal year (FY) 2013 rates for certain filings under the Generic Drug User Fee Program. Specifically, the notice establishes the new annual rates for an abbreviated new drug application (ANDA) ($51,520), prior approval supplement ($25,760), and drug master file … Continue Reading

FDA Meetings on Patient-Focused Drug Development Initiative

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 … Continue Reading

FDA Final Rule Implementing Device Registration and Listing Requirements

This post was written by Erin Janssen. The FDA issued a final rule in August amending current regulations to reflect recent statutory amendments to the device registration and listing provisions of the FD&C Act. The Food and Drug Administration Amendments Act of 2007 (FDAAA), enacted on September 27, 2007, amended the FD&C Act to require … Continue Reading

FDA Establishes FY 2013 User Fee Rates for Biosimilars and Prescription Drugs

This post was written by Erin Janssen. The Food and Drug Administration (FDA) has announced the rates for biosimilar and prescription drug user fees for FY 2013. By way of background, the Federal Food, Drug, and Cosmetic Act (the FD&C Act) authorizes FDA to assess and collect user fees for certain activities in connection with … Continue Reading

Medical Device User Fee Rates for FY 2013

This post was written by Erin Janssen. On July 31, 2012, the FDA published the fee rates and payment procedures for medical device user fees for FY 2013. The fee rates apply from October 1, 2012 through September 30, 2013. To avoid delay in the review of an application, the fee should be paid before or … Continue Reading

FDA Proposes Unique Device Identification System for Medical Devices

This post was written by Erin Janssen. On July 10, 2012, in response to requirements in legislation that passed Congress with broad bipartisan support, the Food and Drug Administration published a proposed rule that would require most medical devices distributed in the United States to carry a unique device identifier, or UDI, except where the … Continue Reading

FDA Final Rule on Disqualification of Clinical Investigators

FDA recently published a final rule that expands the scope of clinical investigator disqualification. Under the rule, when the FDA determines that an investigator is ineligible to receive one kind of test article (drugs, devices, or new animal drugs), the investigator also will be ineligible to conduct any clinical investigation that supports an application for … Continue Reading

FDA Issues Final Rule on Sterility Testing of Biological Products

This post was written by Erin A. Janssen. On May 3, 2012 the FDA issued its final rule on sterility testing, amending the requirements for most licensed biological products effective June 4, 2012.  The rule is intended to promote improvement and innovation in the development of sterility test methods by allowing manufacturers the flexibility needed … Continue Reading

Final Rule Regarding Labeling Requirements for Products Held in Strategic National Stockpile

This post was written by Erin A. Janssen. On February 6, 2012, the FDA adopted as a final rule, without change, the interim final rule from December 28, 2007 that permitted FDA Center Directors to grant exceptions or alternatives to certain regulatory labeling requirements applicable to human drugs, biological products, or medical devices that are … Continue Reading

FDA Seeks Comments on Prescription Drug Promotion Survey

On January 17, 2012 the FDA announced an opportunity for public comment on its Healthcare Professional Survey of Prescription Drug Promotion. This survey is designed to explore the opinions and perceptions of physicians, nurse practitioners, and physician assistants with regard to the promotion of prescription drugs to consumers and healthcare providers. FDA is inviting comments … Continue Reading

FDA Rule Expands Drug Manufacturer Notification Requirements for Potential Drug Shortages

In light of public health concerns related to drug shortages, the Food and Drug Administration (FDA) has issued an interim final rule with comment period to clarify and modify regulations requiring sole manufacturers of certain critical drugs to report to the FDA any interruption in manufacturing that could lead to a potential disruption in supply … Continue Reading

FDA Publishes Notice on Biosimilar Biological Product User Fees

On December 7, 2011, the Food & Drug Administration (FDA) published a notice discussing its proposed recommendations for implementing the ACA’s user fee program for biosimilar biological products for FYs 2013 through 2017. The notice summarizes the four proposed types of fees (Biosimilar Product Development Fees, Marketing Application Fees, Establishment Fees and Product Fees), along with … Continue Reading

FDA Announces Review of Bar Code Final Rule

This post was written by Erin Janssen. The Food and Drug Administration (FDA) has published a notice announcing that it will conduct a review of its 2004 ‘‘Bar Code Final Rule,” which requires certain human drug products and biological products to have a bar code. The rule was intended to help reduce the number of medication … Continue Reading

FDA Proposes Amendments to Orphan Drug Rules

The Food and Drug Administration (FDA) published a proposed rule on October 19, 2011 that would amend the 1992 Orphan Drug Regulations that implement the Orphan Drug Act. The amendments proposed are “intended to assist sponsors who are seeking and who have obtained orphan drug designation of their drugs, as well as FDA in administering … Continue Reading

CMS and FDA Publish Parallel Review Pilot Program Notice

On October 7, 2011, the Centers for Medicare & Medicaid Services and the Food and Drug Administration announced they are soliciting nominations from sponsors of medical devices to participate in a parallel review pilot program. The Agencies officially published a Federal Register notice announcing the program October 11, 2011 (the “Notice”), with an effective date of … Continue Reading

Comment Period Extended for Proposed Rule Regarding Human Subject Protections

This post was written by Erin Janssen. On September 1, 2011, HHS published a notice extending the comment period for the advance notice of proposed rulemaking (ANPRM) on how current regulations for protecting human subjects might be modernized and revised to be more effective. That ANPRM, entitled “Human Subjects Research Protections: Enhancing Protections for Research Subjects … Continue Reading