The Food and Drug Administration (FDA) recently announced changes to its policy on when a comparative efficacy study would be required to demonstrate biosimilarity. In essence, FDA is lopping off the top of the “biosimilarity...more
11/5/2025
/ aBLA ,
Biologics ,
Biosimilars ,
BPCIA ,
Drug Pricing ,
Food and Drug Administration (FDA) ,
Interchangeability ,
New Guidance ,
Patent Litigation ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Regulatory Reform
In the current regulatory environment, both buyers and sellers of companies within the food industry face significant challenges navigating regulatory requirements. In this article, we discuss how to assess and quantify...more
10/29/2025
/ Acquisitions ,
Due Diligence ,
Food & Drug Regulations ,
Food and Drug Administration (FDA) ,
Food Labeling ,
Food Manufacturers ,
Food Safety ,
Indemnification Clauses ,
Mergers ,
New Legislation ,
Regulatory Requirements ,
Risk Management ,
State Legislatures ,
Supply Chain
In-house legal teams are encountering mounting pressure, especially as they balance cost control, risk mitigation and rising litigation of all types. For life sciences companies, the current environment raises the stakes as...more
9/25/2025
/ Abbreviated New Drug Application (ANDA) ,
Class Action ,
Food and Drug Administration (FDA) ,
Generic Drugs ,
Life Sciences ,
Patent Litigation ,
Pharmaceutical Industry ,
Popular ,
Risk Management ,
State Attorneys General ,
Supply Chain
On September 9, 2025, the Department of Health and Human Services (HHS) and Food and Drug Administration (FDA) announced a new initiative to close what the agencies describe as a “loophole” in requirements regarding the...more
9/12/2025
/ Advertising ,
Cease and Desist Orders ,
Department of Health and Human Services (HHS) ,
Enforcement Actions ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Food and Drug Administration (FDA) ,
Pharmaceutical Industry ,
Popular ,
Prescription Drugs ,
Regulatory Oversight ,
Rulemaking Process ,
Social Media ,
Warning Letters
On July 10, 2025, the U.S. Food and Drug Administration (FDA) announced that it was embracing “radical transparency” by publishing more than 200 Complete Response Letters (CRLs) — letters the agency issues to a sponsor when...more
8/26/2025
/ Capital Markets ,
Disclosure Requirements ,
Food and Drug Administration (FDA) ,
Life Sciences ,
Pharmaceutical Industry ,
Popular ,
Publicly-Traded Companies ,
Regulatory Authority ,
Regulatory Oversight ,
Regulatory Requirements ,
Risk Management ,
Securities and Exchange Commission (SEC) ,
Securities Litigation
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
Key Points -
- Who is impacted: Manufacturers of pharmaceutical, biotechnology, medical device and food products.
- What is changing: The agency is prioritizing user fee reauthorization, the MAHA initiative and a push for...more
5/23/2025
/ Biosimilars ,
Executive Orders ,
Food and Drug Administration (FDA) ,
Generic Drugs ,
Healthcare ,
Healthcare Reform ,
Life Sciences ,
Medical Devices ,
Pharmaceutical Industry ,
Prescription Drugs ,
Regulatory Reform ,
Regulatory Requirements ,
Supply Chain ,
Technology
On May 12, 2025, President Donald Trump signed the executive order (EO) “Delivering Most-Favored-Nation Prescription Drug Pricing To American Patients.” The EO sets forth policy positions that attempt to further rein in drug...more
5/14/2025
/ Centers for Medicare & Medicaid Services (CMS) ,
Department of Health and Human Services (HHS) ,
Drug Pricing ,
Executive Orders ,
Healthcare ,
Healthcare Reform ,
Inflation Reduction Act (IRA) ,
Legislative Agendas ,
Medicare ,
New Legislation ,
Pharmaceutical Industry ,
Prescription Drugs ,
Regulatory Agenda ,
Trump Administration
Companies that interact with FDA are likely to find that the layoff of 3,500 employees on April 1, 2025, affects their dealings in a variety of ways....more
On April 22, 2025, Secretary of Health and Human Services Robert F. Kennedy Jr. and Commissioner of the Food and Drug Administration (FDA) Dr. Martin Makary announced that FDA is taking actions to remove petroleum-based dyes...more
4/24/2025
/ Food and Drug Administration (FDA) ,
Food Manufacturers ,
Food Safety ,
Government Agencies ,
Hazardous Substances ,
New Regulations ,
Proposed Rules ,
Regulatory Reform ,
Regulatory Requirements ,
Settlement ,
Toxic Chemicals
Increases in Counterfeit Beauty and Personal Care Products -
The rise of e-commerce has led to increasing sales of counterfeit or noncompliant beauty and personal care products, including many that are knockoffs of...more
There has been a flurry of activity at the Food and Drug Administration (FDA) since the start of the Trump administration. Day-to-day operations at FDA are already significantly altered, and we expect the trickle-down effects...more
In March 2024, Valisure, an independent quality advocate, filed a citizen petition claiming to have detected elevated levels of benzene in benzoyl peroxide acne treatment products. Valisure’s petition included testing results...more
3/28/2025
/ Class Action ,
Cosmetics ,
Food and Drug Administration (FDA) ,
Healthcare ,
Insurance Industry ,
Life Sciences ,
Manufacturers ,
Personal Care Products ,
Regulatory Requirements ,
Risk Management ,
Third-Party ,
Toxic Chemicals
Dr. Martin Makary has been confirmed by the Senate as the next commissioner of the Food and Drug Administration (FDA). Dr. Makary is taking the helm at FDA during an unprecedented time for the agency, which has been subject...more
3/27/2025
/ Department of Government Efficiency (DOGE) ,
Department of Health and Human Services (HHS) ,
Food and Drug Administration (FDA) ,
Healthcare ,
Healthcare Reform ,
Pharmaceutical Industry ,
Prescription Drugs ,
Presidential Appointments ,
Public Health ,
Regulatory Agenda ,
Regulatory Reform ,
Trump Administration
On March 10, 2025, Health Secretary Robert F. Kennedy Jr. initiated a significant shift in the regulation of ultra-processed foods by directing the Food and Drug Administration (FDA) to revise the GRAS (Generally Recognized...more
3/13/2025
/ Department of Health and Human Services (HHS) ,
Enforcement Actions ,
Executive Orders ,
Final Rules ,
Food and Drug Administration (FDA) ,
Food Safety ,
GRAS ,
Healthcare ,
Healthcare Reform ,
Life Sciences ,
Policy Updates ,
Regulatory Reform ,
Regulatory Requirements ,
Rulemaking Process ,
State and Local Government
On February 19, 2025, President Donald Trump issued the executive order “Ensuring Lawful Governance and Implementing the President’s ‘Department of Government Efficiency’ Deregulatory Initiative” (the 2025 EO). The 2025 EO,...more
2/25/2025
/ Administrative Procedure Act ,
Chevron Deference ,
Congressional Review Act ,
Constitutional Challenges ,
Department of Government Efficiency (DOGE) ,
Executive Orders ,
Litigation Strategies ,
Non-Delegation Doctrine ,
OIRA ,
OMB ,
Regulatory Agenda ,
Regulatory Reform ,
Trump Administration
On February 13, 2025, at the swearing-in of Secretary of Health and Human Services (HHS) Robert F. Kennedy Jr., President Donald Trump signed Executive Order “Establishing the President’s Make America Healthy Again...more
Robert F. Kennedy Jr. (RFK Jr.) has been confirmed by the Senate as secretary of the Department of Health and Human Services (HHS). In this capacity, RFK Jr. will oversee 13 agencies that are critical to U.S. health policy,...more
2/13/2025
/ Alternative Medicine ,
Centers for Medicare & Medicaid Services (CMS) ,
Department of Health and Human Services (HHS) ,
Executive Orders ,
Federal Funding ,
Food and Drug Administration (FDA) ,
Food Labeling ,
Healthcare ,
Healthcare Reform ,
National Institute of Health (NIH) ,
Pharmaceutical Industry ,
Popular ,
Regulatory Agenda ,
Regulatory Reform ,
Research and Development ,
Trump Administration ,
Vaccinations
Since the announcement that president-elect Donald Trump would nominate Robert F. Kennedy Jr. (RFK Jr.) as the secretary of the U.S. Department of Health and Human Services (HHS), media reports have featured opinions from...more
1/23/2025
/ Department of Health and Human Services (HHS) ,
Drug Safety ,
Food and Drug Administration (FDA) ,
GRAS ,
Medical Devices ,
Pharmaceutical Industry ,
Public Health ,
Regulatory Reform ,
Regulatory Requirements ,
Trump Administration ,
User Fees
Key Points -
- It remains to be seen what priorities Robert F. Kennedy Jr. and Marty Makary might set if confirmed as HHS secretary and FDA commissioner, respectively.
- The Trump administration will likely focus on drug...more
1/21/2025
/ Affordable Care Act ,
Artificial Intelligence ,
Centers for Medicare & Medicaid Services (CMS) ,
Cybersecurity ,
Data Privacy ,
Department of Health and Human Services (HHS) ,
Department of Justice (DOJ) ,
Drug Pricing ,
Food and Drug Administration (FDA) ,
Healthcare ,
Healthcare Fraud ,
Healthcare Reform ,
Inflation Reduction Act (IRA) ,
Medical Devices ,
Pharmaceutical Industry ,
Regulatory Agenda ,
Regulatory Reform ,
Secretary of HHS ,
Trump Administration
The Food and Drug Administration’s (FDA or Agency) final rule on Additional Conditions for Nonprescription Use (ACNU) paves the way for some drugs that are currently available only with a prescription to switch to OTC where a...more
What Are GLP-1s? Glucagon-like peptide-1 receptor agonists, also known as GLP-1 drugs, are a class of medications that mimic the action of the glucagon-like peptide-1 hormone, which is involved in the regulation of blood...more