Nikita Bhojani at Morgan Lewis

Navigating FDA’s Evolving Approach to Guidance Publication for Medical Products

Guidance development and publication from the Food and Drug Administration (FDA) has long been considered an essential element of medical product development, approval, and regulation. While temporary pauses in guidance...more

6/10/2025 / Coronavirus/COVID-19 , Drug Pricing , Executive Orders , Food and Drug Administration (FDA) , Generic Drugs , Medical Devices , New Guidance , Public Health , Regulatory Reform , Rulemaking Process

From Offshore to Onshore: Considerations for Pharmaceutical Industry Stakeholders Amid New Domestic Drug Manufacturing EO

The White House on May 5, 2025 issued an executive order requiring the US Food and Drug Administration to find ways to facilitate the opening of new drug manufacturing sites in the United States while also increasing the...more

5/9/2025 / Executive Orders , Food and Drug Administration (FDA) , Imports , Manufacturers , National Security , Pharmaceutical Industry , Regulatory Oversight , Regulatory Requirements , Supply Chain , Tariffs

FDA's Recent Release of a Roadmap to Reduce Animal Testing

The US Food and Drug Administration (FDA) recently announced a strategic roadmap to phase out animal testing requirements for certain drug products, starting with monoclonal antibodies. This shift marks a significant change...more

4/28/2025 / Animal Testing , Biotechnology , Food and Drug Administration (FDA) , Innovative Technology , Life Sciences , Machine Learning , Pharmaceutical Industry , Prescription Drugs , Regulatory Reform , Research and Development

Food Safety 3.0: FDA Implements Human Foods Program Alongside Long-Awaited Reorganization

On October 1, 2024, the US Food and Drug Administration (FDA) announced the implementation of its long-promised reorganization, with the establishment of the unified Human Foods Program (HFP). The HFP now oversees all FDA...more

10/25/2024 / Dietary Supplements , Food and Drug Administration (FDA) , Food Manufacturers , Food Safety

The Horse Is Out of the Barn: FDA and AAFCO Memo of Understanding on Animal Feed Ingredients to Expire

The Association of American Feed Control Officials (AAFCO) and the US Food and Drug Administration (FDA) announced on August 2, 2024 that their long-standing Memorandum of Understanding (MOU) governing the development and...more

8/20/2024 / Animal Food , Food and Drug Administration (FDA) , Food Manufacturers , Food Safety , Food Supply

FDA Issues Guidance on Foods Made from Genome-Edited Plants in Newest Update to Its ‘Plant-Based Cookbook’

The US Food and Drug Administration (FDA) issued final guidance titled Foods Derived from Plants Produced Using Genome Editing (Genome-Edited Plants Guidance), describing the agency’s approach for evaluating the safety of...more

8/1/2024 / Comment Period , Food and Drug Administration (FDA) , New Guidance , Public Comment

That’s a Wrap: FDA Announces Phase-Out of PFAS in Certain Food-Packaging Materials

The US Food and Drug Administration (FDA) recently announced that manufacturers have completed the voluntarily phase-out of the use of certain per- and polyfluoroalkyl substances (PFAS) in grease-proofing agents for food...more

4/8/2024 / Food and Drug Administration (FDA) , Food Manufacturers , Food Safety , Hazardous Substances , PFAS , Product Packaging , Toxic Chemicals

FDA Releases Guidance on Data Monitoring Committees for Clinical Trial Management

The US Food and Drug Administration (FDA) recently issued draft guidance with recommendations to help clinical trial sponsors determine when a data monitoring committee (DMC) would be beneficial for managing clinical trials...more

4/2/2024 / Clinical Trials , Comment Period , Draft Guidance , Food and Drug Administration (FDA) , Life Sciences

Real-World Evidence: Non-Interventional Studies in Support of Substantial Evidence of Effectiveness

The US Food and Drug Administration (FDA) issued draft guidance, providing recommendations to sponsors who are considering submitting a non-interventional study (i.e., an observational study) to FDA to support the...more

3/26/2024 / Evidence , Food and Drug Administration (FDA) , Pharmaceutical Industry , Prescription Drugs

FDA Rounds Out 2023 with Advanced Manufacturing Technologies Designation Program Guidance

As the close of 2023 approaches, the US Food and Drug Administration (FDA) has issued draft guidance detailing its new Advanced Manufacturing Technologies Designation Program, intended to facilitate the development and...more

12/21/2023 / Food and Drug Administration (FDA) , Life Sciences , Manufacturers , Pharmaceutical Industry , Prescription Drugs

Salt-Shaking it Up: FDA Issues Proposed Rule to Allow Salt Substitutes in Standardized Foods

FDA has consistently pursued its aim of encouraging US consumers to eat less salt. As we have previously written, FDA issued a Voluntary Sodium Reduction guidance in October 2021 to support the reduction of average sodium...more

6/14/2023 / Comment Period , Dietary Guidelines , Food & Drug Regulations , Food and Drug Administration (FDA) , Food Labeling , Food Manufacturers , Nutrition Facts Labels , Proposed Rules , Regulatory Agenda , Regulatory Reform

A Sweet Deal: FDA Allows New Qualified Heart-Healthy Claim for High Flavanol Cocoa Powder

FDA recently announced it does not object to the use of certain qualified health claims regarding the relationship between the consumption of cocoa flavanols in high flavanol cocoa powder and a reduced risk of cardiovascular...more

5/2/2023 / Food and Drug Administration (FDA) , Food Labeling , Food Manufacturers , Food Marketing , Health Claims , Nutrition Facts Labels , Regulatory Agenda

Monograph Soup: The ABCs & XYZs for OTCs on Formal Meetings with FDA

The US Food and Drug Administration (FDA) on February 1 issued a draft guidance, “Formal Meetings Between FDA and Sponsors or Requestors of OTC Monograph Drugs” (Meeting Guidance), that specifies the procedures and principles...more

2/15/2022 / Administrative Orders , CARES Act , Draft Guidance , Federal Food Drug and Cosmetic Act (FFDCA) , Food and Drug Administration (FDA) , Over The Counter Drugs (OTC) , Pharmaceutical Industry

Fourth Circuit Best Price Decision Highlights Role of Medicaid Drug Rebate Program Reasonable Assumptions

The US Court of Appeals for the Fourth Circuit decision in US ex rel. Sheldon v. Allergan Sales, LLC acknowledges the complexity of price calculations under the Medicaid Drug Rebate Statute and highlights the importance of...more

2/2/2022 / Drug Pricing , False Claims Act (FCA) , Medicaid , Medicaid Drug Rebate Program , Pharmaceutical Industry , Prescription Drugs

A Pinch of Salt, but No Pepper(ing) This Time: FDA Issues Voluntary Guidance on Sodium Reduction

FDA issued a Voluntary Sodium Reduction guidance in October 2021, aimed to help Americans reduce average daily sodium intake over the next two and a half years. The guidance suggests voluntary sodium reduction targets for...more

11/4/2021 / Food and Drug Administration (FDA) , Food Labeling , Food Manufacturers , Food Safety , Food Supply , Nutrition Facts Labels , Public Health , Regulatory Requirements

Anti-Spoil(er) Alert: FDA Issues Guidance on Antimicrobial Agents in Food

FDA issued an updated Q&A guidance in September 2021, Microbiological Considerations for Antimicrobial Agents Used in Food Applications: Guidance for Industry (Antimicrobial Agents Guidance), which replaces a guidance...more

10/13/2021 / Antimicrobials , Environmental Protection Agency (EPA) , Federal Food Drug and Cosmetic Act (FFDCA) , Food and Drug Administration (FDA) , Food Safety , Life Sciences , Memorandum of Understanding , Public Health , USDA

Nikita Bhojani

Morgan Lewis

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