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Regulatory Oversight › New Regulations › Food and Drug Administration (FDA)

Ropes & Gray LLP

FDA Finalizes Guidance on Remote Regulatory Assessments, But How Will They Support the Administration’s Manufacturing-Related...

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In response to travel restrictions imposed during the COVID-19 pandemic, the U.S. Food and Drug Administration (“FDA”) began conducting remote regulatory assessments (“RRAs”) of medical products companies and other...more

Sheppard Mullin Richter & Hampton LLP

What’s Going on with Human Cell and Tissue Products?

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Since the publication of our article on what to expect for stem cell regulation under the new administration, we’ve been closely monitoring the administration’s enhanced focus on the same....more

Husch Blackwell LLP

FDA Launches Commissioner’s National Priority Voucher Program: What Life Sciences Innovators Need to Know

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On June 17, 2025, the Food and Drug Administration (FDA) announced the Commissioner’s National Priority Voucher (CNPV) program, a bold initiative designed to accelerate the review of therapies addressing critical national...more

Hogan Lovells

FDA Commissioner’s National Priority Voucher program comes with questions surrounding implementation

Hogan Lovells on

The U.S. Food and Drug Administration (FDA) announced Tuesday a “Commissioner’s National Priority Voucher” (CNPV) program, which will provide a “limited number” of vouchers to sponsors of drug products that are “aligned with...more

Skadden, Arps, Slate, Meagher & Flom LLP

FDA Commissioner Launches Pilot Program To Speed Review of Certain Drugs

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On June 17, 2025, U.S. Food and Drug Administration (FDA) Commissioner Marty Makary announced that the agency is creating a new pilot program called the Commissioner’s National Priority Voucher (CNPV). The program is intended...more

Venable LLP

May 2025 Stelara® and Humira® Interchangeable Biosimilar Approvals

Venable LLP on

In May 2025, the FDA approved numerous biosimilars as interchangeable with Stelara® (ustekinumab) and Humira® (adalimumab), bringing the total number of Stelara® interchangeables to four, plus an additional biosimilar (Sandoz...more

Gardner Law

Staying Prepared Amid FDA Changes

Gardner Law on

Despite recent staffing reductions and leadership transitions at the FDA, pharmaceutical and medical device manufacturers should not interpret these changes as a signal of reduced regulatory enforcement. On the contrary, the...more

Morgan Lewis - Well Done

Food for Thought Implications of FDAs New Chemical Review Program

Morgan Lewis - Well Done on

The US Food and Drug Administration recently announced a major initiative to strengthen oversight of food additives and other food-related chemicals. The agency described this as a “stronger, more systematic review process”...more

Hogan Lovells

FDA announces expanded use of unannounced inspections at foreign manufacturing facilities

Hogan Lovells on

On May 6, 2025, the U.S. Food and Drug Administration (FDA) announced that it intends to expand its use of unannounced inspections at foreign manufacturing facilities. This announcement applies to facilities that produce...more

Venable LLP

Food Industry Braces Itself as FDA Announces Plan to Ban Artificial Dyes

Venable LLP on

On April 21, 2025, it was reported that the U.S. Department of Health and Human Services (HHS) has released a media advisory describing the Food and Drug Administration’s (FDA) intention to remove petroleum-based synthetic...more

Troutman Pepper Locke

FDA’s New Lead Guidelines: A Milestone for Safer Baby Foods

Troutman Pepper Locke on

In recent years, the safety of baby food has become a top priority for state attorneys general (AG) and federal agencies. In April 2021, the U.S. Food and Drug Administration (FDA) announced its “Closer to Zero” plan to...more

ArentFox Schiff

FDA Finds Significant Bioequivalence Concerns in Raptim Studies Leading to ANDA and NDA Reviews

ArentFox Schiff on

In a highly unusual move, on March 27, the US Food and Drug Association (FDA) issued a Drug Safety Notice that calls into question both pending and approved abbreviated new drug applications (ANDAs) and new drug applications...more

Foley Hoag LLP

Congress Adds Some Teeth to FDA’s Authority to Regulate Cosmetics

Foley Hoag LLP on

The Food and Drug Administration (FDA) now has additional regulatory authorities over cosmetics, thanks to the Food and Drug Omnibus Reform Act (FDORA). FDORA was a part of the Consolidated Appropriations Act, 2023 (the...more

Perkins Coie

Ninth Circuit Rules on Legality of Delta-8 THC Products

Perkins Coie on

On May 19, 2022, the U.S. Circuit Court of Appeals for the Ninth Circuit issued an opinion holding that Delta-8 THC products are legal at the federal level and eligible for intellectual property protection...more

Mintz - Health Care Viewpoints

Paradigm Shift: Regulating Software as a Medical Device in the U.S.

Mintz - Health Care Viewpoints on

The U.S. Food and Drug Administration (FDA) is exploring the development of a new regulatory approach for software as a medical device (SaMD) that the agency believes will promote innovation while still assuring device safety...more

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