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Biotechnology › Regulatory Oversight › Food and Drug Administration (FDA)

Alston & Bird

Feds Continue to Reform Approach to Regulation of Biotech Products

Alston & Bird on

Our Food & Beverage and FDA teams explore a plan from a trio of federal agencies that seeks to implement regulatory reform and update the Coordinated Framework for the Regulation of Biotechnology....more

Nelson Mullins Riley & Scarborough LLP

Minimizing the Fallout from Increasing FDA Clinical Holds

Nelson Mullins Riley & Scarborough LLP on

With medical and scientific advances progressing at an exponential pace, FDA appears to be taking a more aggressive stance in imposing clinical holds on studies where adverse events are reported. Over the last several years,...more

Morgan Lewis - Well Done

USDA’s Proposal to Take Back Regulatory Oversight of GM Animals from FDA Remains Viable Despite Change in Administration

Morgan Lewis - Well Done on

On December 14, 2020, the US Food and Drug Administration (FDA) approved GalSafe pigs, which are genetically modified (GM) for use in food production and medical products. At the time, the agency noted in its Consumer Q&A...more

Robinson+Cole Health Law Diagnosis

Bipartisan Bill for Federal Regulation of CBD in Foods and Dietary Supplements

Robinson+Cole Health Law Diagnosis on

A bipartisan bill was introduced in the U.S. House of Representatives on January 13, 2020, that (1) would allow hemp-derived cannabidiol (CBD) to be regulated as a dietary supplement, if all of the other applicable...more

Mintz - Consumer Product Safety Viewpoints

Regulatory Agencies Launch Unified Website for Biotechnology Regulation

Mintz - Consumer Product Safety Viewpoints on

In a coordinated effort, the Food and Drug Administration (FDA), the U.S. Department of Agriculture (USDA), and the Environmental Protection Agency (EPA) launched a Unified Website for Biotechnology Regulation on January 9,...more

Wilson Sonsini Goodrich & Rosati

FDA Issues Final Guidance on PDUFA Waivers, Reductions, and Refunds

Wilson Sonsini Goodrich & Rosati on

The Prescription Drug User Fee Act of 2017 (PDUFA VI) authorizes the U.S. Food and Drug Administration (FDA) to assess fees (PDUFA fees) when applicants submit new drug applications (NDAs). PDUFA fees are substantial. For...more

Hogan Lovells

Will FDA be forced to implement a drug importation program?

Hogan Lovells on

Over a year ago, HHS Secretary Alex Azar requested that FDA establish a working group to explore how drug importation “could help address price hikes and supply disruptions.” The FDA working group was not assigned the task of...more

Wilson Sonsini Goodrich & Rosati

FDA Target of Executive Order on Agricultural Biotechnology

Wilson Sonsini Goodrich & Rosati on

In response to concerns expressed by livestock groups and some in the biotechnology industry over the Food and Drug Administration's (FDA's) approval process for gene editing in animals, the Trump administration issued an...more

Hogan Lovells

FDA publishes final guidance on ANDA/505(b)(2) NDA pathways

Hogan Lovells on

On Thursday, FDA published the final guidance document, “Determining Whether to Submit an ANDA or a 505(b)(2) Application” that contains minor revisions to the October 2017 draft guidance. ...more

Hogan Lovells

New FDA draft guidance on voluntary recalls highlights importance of recall initiation plans

Hogan Lovells on

On April 23, FDA issued draft guidance entitled “Initiation of Voluntary Recalls Under 21 CFR Part 7, Subpart C,” which aims to clarify how firms in a product distribution chain should prepare to facilitate timely initiation...more

Hogan Lovells

With the Statutory Deadline Approaching, FDA Issues a Proposed Sunscreens Rule

Hogan Lovells on

On February 26, FDA published the proposed rule, “Sunscreen Drug Products for Over-the-Counter Human Use,” which describes the conditions under which Over-the-Counter (OTC) sunscreen monograph products are generally...more

Holland & Knight LLP

Food and Beverage Law Update: December 2018

Holland & Knight LLP on

Regulation - FDA-USDA Propose Joint Regulatory Framework for Cell-Grown Meat - On Nov. 16, 2018, the U.S. Food and Drug Administration (FDA) and the U.S. Department of Agriculture (USDA) issued a joint statement...more

Hogan Lovells

FDA Releases Plant and Animal Biotechnology Innovation Action Plan

Hogan Lovells on

The U.S. Food and Drug Administration (FDA) recently released its Plant and Animal Biotechnology Innovation Action Plan (“Action Plan”). The Action Plan provides an overview of the key priorities FDA expects to pursue through...more

BCLP

Battle Heats Up Concerning Regulatory Jurisdiction Over Cultured Meat Products

BCLP on

The next wave of emerging agricultural biotechnology is set for its first regulatory showdown. Cell-cultured meat (“CCM”) allows your steak to be grown in a lab by replicating animal cells. Some CCM products are even created...more

Hogan Lovells

FDA proposes streamlining combination product regulations

Hogan Lovells on

On May 15, 2018, the Food and Drug Administration (FDA) proposed amending its product classification rules for combination products, found in 21 CFR Part 3. Generally, the proposed rule purports to clarify language in the...more

Hogan Lovells

Institutional Review Board “Checklist” offers tool to help protect clinical trial participants

Hogan Lovells on

On May 17, HHS’s Office for Human Research Protections (OHRP) and FDA issued a joint, final guidance on written procedures for institutional review boards (IRBs). ...more

Hogan Lovells

FDA Issues New Guidance Documents on Regenerative Medicine but Delays Enforcement

Hogan Lovells on

Last week, the U.S. Food and Drug Administration (FDA) announced a comprehensive framework for development and oversight of regenerative medicine products, including innovative cell-based therapies. ...more

Hogan Lovells

Unburden Yourself: FDA Requests Comments on Ways to Implement President Trump's Regulatory Reform Executive Orders

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Earlier this year, in an effort to alleviate unnecessary regulatory burdens, President Trump issued two executive orders, Executive Order 13771, Reducing Regulatory and Controlling Regulatory Costs and Executive Order 13777,...more

Hogan Lovells

There'll Be Some Changes Made: President Signs Prescription Drug and Biologic User Fee Reauthorization Act

Hogan Lovells on

On August 18, 2017, President Trump signed into law the FDA Reauthorization Act (FDARA). FDARA reauthorizes user fees paid to FDA to support regulatory review of innovator drugs and biologics, medical devices, generic drugs,...more

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