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
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
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
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
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