Bryant Godfrey on Food and Drug Administration (FDA)

U.S. Department of Commerce Investigates Possible Tariffs on Pharmaceuticals: Forecasting the Impact and an Opportunity to Comment

I. Key Takeaways - - The Secretary of Commerce is investigating the effects of imports of pharmaceuticals and pharmaceutical ingredients (and their derivative products) on national security to support potential tariffs or...more

4/18/2025 / Biologics , Comment Period , Drug Pricing , Food and Drug Administration (FDA) , Imports , Medical Devices , National Security , Pharmaceutical Industry , Prescription Drugs , Supply Chain , Tariffs , Trade Expansion Act of 1962 , Trade Relations , U.S. Commerce Department

HHS Under the Second Trump Administration

On February 11, 2025, President Trump signed Executive Order (E.O.) 14210, Implementing The President’s “Department of Government Efficiency” Workforce Optimization Initiative, which instructed the newly formed Department of...more

4/2/2025 / Centers for Medicare & Medicaid Services (CMS) , Department of Health and Human Services (HHS) , Drug Pricing , Executive Orders , Food and Drug Administration (FDA) , Healthcare , Healthcare Reform , Loper Bright Enterprises v Raimondo , Regulatory Reform , Rulemaking Process , Trump Administration

FDA Finalizes Guidance on Scientific Information on Unapproved Uses (SIUU) Communications

On January 6, 2025, FDA published a final version of its guidance document, “Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared Medical Products.” This...more

2/10/2025 / Final Guidance , Final Rules , Food and Drug Administration (FDA) , Health Care Providers , Healthcare , Life Sciences , Medical Devices , Pharmaceutical Industry , Prescription Drugs , Regulatory Requirements

Fostering More Access to Medical Devices: FDA’s Efforts to Advance Health Equity

On August 5, 2024, FDA’s Center for Devices and Radiological Health (CDRH) published a discussion paper entitled, “Discussion Paper: Health Equity For Medical Devices” (Discussion Paper), to aid in its efforts to advance...more

8/14/2024 / CDRH , Clinical Evaluations , Discussion Draft , Food and Drug Administration (FDA) , Healthcare , Innovative Technology , Medical Devices , Patients , Regulatory Requirements

Loper Bright's Implications for the Food and Drug Administration and Regulated Industry

Under the Chevron doctrine, FDA and other agencies had significant flexibility to set policy where Congress left a gap or failed to speak clearly when enacting legislation—a common occurrence given the at-times sparse...more

7/23/2024 / Chevron Deference , Decision-Making Process , Food and Drug Administration (FDA) , Government Agencies , Judicial Authority , Laboratory Developed Tests , Life Sciences , Loper Bright Enterprises v Raimondo , Regulatory Authority , SCOTUS , Statutory Interpretation

Want to Say It Ain't So? FDA Guides Firms on How to Respond to Misinformation

Health providers and consumers increasingly rely on the internet for health and medical-related information, but not all such information is reliable, and many statements are downright false. The proliferation of social media...more

7/15/2024 / Draft Guidance , Enforcement , False Statements , Federal Food Drug and Cosmetic Act (FFDCA) , Food and Drug Administration (FDA) , Internet , Medical Devices , Pharmaceutical Industry , PHSA , Policy Statement , Prescription Drugs , Regulatory Reform

Action Plans on Diversity: Key Requirements for Certain Clinical Studies

On June 26, 2024, FDA issued a new draft guidance on clinical trial diversity, “Diversity Action Plans to Improve Enrollment of Participants from Underrepresented Populations in Clinical Studies” (Draft Guidance), to assist...more

7/12/2024 / Clinical Trials , Diversity , Draft Guidance , Food and Drug Administration (FDA) , Laboratory Developed Tests , Life Sciences , Medical Devices , Patient Privacy Rights , Pharmaceutical Industry , Prescription Drugs

States Wade into FDA Regulatory Territory to Address Chemicals in Foods and Personal Care Products

Increased public health interest in “forever chemicals” is leading to a new, complex regulatory landscape for manufacturers, distributors, and retailers of foods, cosmetics, and other consumer products. As FDA and other...more

6/25/2024 / Chemicals , Food and Drug Administration (FDA) , Pending Legislation , Personal Care Products , PFAS , Proposed Legislation , Regulatory Agenda , State Bans

In Search of Harmonization: FDA Finalizes Device CGMP Regulation Harmonization with ISO 13485:2016

On February 2, 2024, FDA finalized its nearly two-year-long process to harmonize QS regulations with ISO standards. As we mentioned when FDA proposed the harmonization in 2022, this update represents the first update to the...more

2/8/2024 / CGMP , Federal Food Drug and Cosmetic Act (FFDCA) , Final Rules , Food and Drug Administration (FDA) , ISOs , Medical Devices , Regulatory Agenda , Regulatory Requirements

FDA’s Major Statement: The Agency’s Recent Direct-to-Consumer CCN Final Rule, Q&A Guidance and Enforcement Trends

On December 26, 2023, the Food and Drug Administration (FDA) released a Small Entity Compliance Guide Final Guidance Document: Direct-to-Consumer Prescription Drug Advertisements: Presentation of the Major Statement in a...more

1/3/2024 / Advertising , Direct to Consumer Sales , Enforcement Actions , Federal Food Drug and Cosmetic Act (FFDCA) , Final Rules , Food and Drug Administration (FDA) , Food and Drug Administration Amendments Act (FDAAA) , New Guidance , Prescription Drugs

FDA Issues Revised Draft Guidance on “Scientific Information on Unapproved Uses Communications”

On October 23, 2023, FDA published a draft guidance document to provide detailed recommendations to industry regarding the communication of unapproved uses of approved or cleared drugs and medical devices to health care...more

10/25/2023 / Draft Guidance , Food and Drug Administration (FDA) , Health Care Providers , Healthcare , Healthcare Reform , Labeling , Medical Devices , Medical Software , Pharmaceutical Industry , Policies and Procedures , Regulatory Requirements , Regulatory Standards

FDA Publishes Long-Awaited In Vitro Diagnostics Proposed Rule – Medical Device Regulations Would Apply to Laboratory Developed...

FDA published a proposed rule that would regulate IVDs, including LDTs, as medical devices, drastically altering the regulatory landscape for LDTs. The proposed rule would update the definition of IVDs in 21 CFR § 809.3 to...more

10/3/2023 / CDRH , Clinical Laboratory Testing , Comment Period , Food and Drug Administration (FDA) , Healthcare , Manufacturers , Medical Devices , Proposed Rules , Regulatory Requirements

FDA and Prescription Drug Use Related Software – FDA’s Draft PDURS Guidance Answers Years-Old Questions and Introduces New Ones

After remaining silent on the topic for decades, the Food and Drug Administration (FDA) provided an expansive definition of “promotional labeling” in its recently issued draft guidance document on Regulatory Considerations...more

9/26/2023 / Comment Period , Draft Guidance , Food and Drug Administration (FDA) , Healthcare Reform , Labeling , Pharmaceutical Industry , Prescription Drugs , Public Comment , Regulatory Requirements , Software

The Cannabis Rescheduling Recommendation: What it Means and What’s Next

In light of the August 30, 2023 historic recommendation from the U.S. Department of Health and Human Services (HHS) to reschedule cannabis to Schedule III, a multidisciplinary group of attorneys from Foley Hoag’s nationwide...more

9/1/2023 / Cannabidiol (CBD) oil , Cannabis Products , Controlled Substances , Controlled Substances Act , Criminal Penalties , DEA , Department of Health and Human Services (HHS) , Food and Drug Administration (FDA) , Legislative Agendas , Marijuana , Medical Marijuana , Schedule I Drugs

Big Four Health Committee Leaders Release Request for Information on Regulation of Cannabidiol

On July 27, 2023, House Energy and Commerce Committee Chair Cathy McMorris Rodgers (R-WA) and Ranking Member Frank Pallone, Jr., (D-NJ), along with Senate Health, Education, Labor, and Pensions (HELP) Committee Chair Bernie...more

8/2/2023 / Cannabis Products , Comment Period , Controlled Substances Act , Food and Drug Administration (FDA) , Labeling , Legislative Agendas , Product Packaging , Proposed Legislation , Regulatory Agenda , Regulatory Requirements

OPDP Issues Final Guidance on Best Practices for Presenting Quantitative Efficacy and Risk Information in Direct-to-Consumer...

On June 27, 2023, the Food and Drug Administration’s ("FDA") Office of Prescription Drug Promotion ("OPDP") published a final guidance (the "Final Guidance") on Presenting Quantitative Efficacy and Risk Information in...more

7/11/2023 / Advertising , Direct to Consumer Sales , Final Guidance , Food & Drug Regulations , Food and Drug Administration (FDA) , Labeling , Marketing , OPDP , Over The Counter Drugs (OTC) , Pharmaceutical Industry , Prescription Drugs

United States v. Elizabeth Holmes and Ramesh Balwani

I. WHY THIS CASE MADE THE LIST - A highly publicized and long-running multi-agency action against the former Chief Executive Officer and the former Chief Operating Officer of Theranos Inc. resulted in criminal convictions...more

FDA Completes Second Premarket Consultation for Cultivated Meat Production, While Italy Bans Cell-Based Food

Four months after completing its first premarket consultation, the Food and Drug Administration (FDA) cleared its second premarket consultation for cell-cultivated meat production. We wrote about the first premarket...more

5/12/2023 / Department of Agriculture , EU , Food and Drug Administration (FDA) , Food Safety , Meat Processing Plants , UK , United Nations , USDA

Bills Reintroduced in Congress After FDA Signals Potential New Regulatory Pathway for Cannabidiol Products

On the heels of a January 2023 statement released by the FDA expressing the need for a new regulatory pathway for cannabidiol products, two CBD-related bills were reintroduced in the House of Representatives on March 17,...more

4/3/2023 / Cannabidiol (CBD) oil , Farm Bill , Food and Drug Administration (FDA) , Legislative Agendas , Proposed Legislation , Regulatory Agenda , Regulatory Reform

New Regulatory Pathway for Cannabidiol Products May be Forthcoming

The Food and Drug Administration (FDA) released a statement yesterday explaining its conclusion that a new regulatory pathway is needed to allow for greater oversight and to better manage risks associated with cannabidiol...more

1/30/2023 / Cannabis Products , Enforcement , Food and Drug Administration (FDA) , Labeling , Marijuana , New Regulations , Regulatory Agenda , Risk Management

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

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

1/19/2023 / Cosmetics , Federal Food Drug and Cosmetic Act (FFDCA) , Food and Drug Administration (FDA) , Manufacturers , New Regulations , Personal Care Products , Product Labels , Product Safety Labels , Proposed Legislation , Registration Requirement , Regulatory Oversight , Reporting Requirements

FDA Issues Draft Guidance Recommending "Race and Ethnicity Diversity" Plans for Clinical Trial Sponsors

Key Takeaways: The draft guidance represents the first-ever specific expectation by FDA that sponsors develop a diversity plan for trials. FDA’s recommendations come as part of increasing interest in ensuring clinical...more

4/20/2022 / Abbreviated New Drug Application (ANDA) , Biden Administration , Biologics , Black and Minority Ethnic (BME) , Clinical Trials , Corporate Counsel , Data Collection , Department of Health and Human Services (HHS) , Diversity , Draft Guidance , FDASIA , Food and Drug Administration (FDA) , Investigational New Drug Application (IND) , Licenses , National Institute of Health (NIH) , Premarket Approval Applications , Sponsors

10/29/2021 / Artificial Intelligence , Food and Drug Administration (FDA) , Health Canada , Healthcare , International Medical Device Regulators Forum (IMDRF) , Machine Learning , Medical Devices , Medicines and Healthcare Products Regulatory Agency (MHRA) , New Guidance , Regulatory Oversight , Technology Sector

Bryant Godfrey

Foley Hoag LLP

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