Archives: Food & Drug Administration Regulations

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FDA to Overhaul an OTC System That “Isn’t Working”

This post was also written by 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 … Continue Reading

Coming to a TV Near You? FDA Seeks Public Input on Limiting Risks Presented in Direct-to-Consumer Television Ads

In a notice published in the Federal Register on February 18, 2014, the Food and Drug Administration (FDA) asked for feedback on a proposed research study related to prescription drug television advertisements. The study, Disclosure Regarding Additional Risks in Direct-to-Consumer (DTC) Prescription Drug Television (TV) Advertisements (Ads), would investigate the impact of limiting the risks … Continue Reading

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As reported on our Life Sciences Legal Update blog, the FDA has issued draft guidance addressing the unique challenges of drug promotion in the age of social media. Specifically, the draft guidance addresses how to submit interactive promotional media for postmarket review.  Comments on the document, “Draft Guidance for Industry on Fulfilling Regulatory Requirements for Postmarketing … Continue Reading

CMS, FDA Extend Pilot Program for Parallel Review of Medical Products

In October 2011, CMS and the FDA formally launched a voluntary parallel review pilot program for sponsors of medical devices. At the time, the agencies stated that they intended to run the pilot program for two years, with the possibility of an extension. In a December 18, 2013 notice, the FDA and CMS announced that … Continue Reading

FDA Releases Final Guidance on Qualification Process for Drug Development Tools

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 … Continue Reading

FDA Proposes New Rule to Exercise its Administrative Detention Authority for Drugs

On July 15, 2013, the Food and Drug Administration (FDA) published in the Federal Register a proposed rule that would amend 21 CFR Part 1 to implement FDA’s detention authority with respect to drugs intended for human or animal use. FDA’s detention authority is authorized by amendments made to the Food, Drug, and Cosmetic Act … Continue Reading

FDA Amends Orphan Drug Regulations

On June 12, 2103 the Food and Drug Administration (FDA) published a final rule amending the orphan drug regulations (21 CFR Part 316). The amendments are intended to clarify regulatory provisions and make minor improvements to address issues regarding orphan drug designation and orphan drug exclusivity. The final rule largely finalizes the amendments as proposed … Continue Reading

FDA Issues New Guidance Documents

In recent weeks, the Food and Drug Administration (FDA) has issued a number of new draft and final guidance documents on a range of issues, including financial disclosure by clinical investigators, medical device recalls, prescription drug labeling, and medical devices for pediatric uses. Highlights include the following: Financial Disclosure by Clinical Investigators. This final guidance … Continue Reading

FDA Issues Final Rule on Current Good Manufacturing Practice Requirements for Combination Products

FDA has issued a final rule on the current good manufacturing practice (CGMP) requirements applicable to combination products. The rule clarifies which CGMP requirements apply when drugs, devices, and biological products are combined to create combination products. For certain types of combination products the application of CGMP requirements is straightforward – the constituent parts of … Continue Reading

FDA Announces 2013 Generic Drug Active Pharmaceutical Ingredient and Finished Dosage Form Facility User Fee Rates

The FDA has announced the generic drug active pharmaceutical ingredient (API) and finished dosage form (FDF) facility user fee rates for fiscal year 2013. The API facility fee is owed by each person that owns a facility which produces, or which is pending review to produce, one or more APIs identified, or intended to be … Continue Reading

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