On June 12, 2025, Senators Bernie Sanders (I-Vt.) and Angus King (I-Maine) introduced the End Prescription Drug Ads Now Act, with Senators Chris Murphy (D-Conn.), Peter Welch (D-Vt.), Jeff Merkley (D-Ore.), and Dick Durbin...more
7/9/2025
/ Advertising ,
Constitutional Challenges ,
Department of Health and Human Services (HHS) ,
Direct to Consumer Sales ,
FDCPA ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
First Amendment ,
Food and Drug Administration (FDA) ,
Government Agencies ,
Pharmaceutical Industry ,
Prescription Drugs ,
Proposed Legislation ,
Regulatory Reform
FDA issued a draft guidance that lays the groundwork for drug companies to comply with changes to approved color additives....more
The initiatives reflect the latest measures from federal agencies to reduce and ultimately replace animal testing in drug development and biomedical research....more
Recent developments include leadership changes, workforce reductions, and policy shifts at HHS and FDA, reshaping agency operations under President Trump’s administration....more
5/16/2025
/ Department of Health and Human Services (HHS) ,
Deregulation ,
Enforcement Priorities ,
Executive Orders ,
Food and Drug Administration (FDA) ,
Government Agencies ,
Life Sciences ,
Reduction of Force ,
Regulatory Agenda ,
Reorganizations ,
Rulemaking Process ,
Trump Administration
Food product manufacturers should prepare for FDA to pursue statutory and regulatory changes to phase out the use of certified color additives in food.
On April 22, 2025, HHS and FDA announced a series of highly...more
On April 2, 2025, the Supreme Court unanimously held that the US Food and Drug Administration (FDA) lawfully denied marketing authorization for certain flavored e-liquids used in electronic nicotine delivery systems (ENDS),...more
On March 10, 2025, Department of Health and Human Services (HHS) Secretary Robert F. Kennedy Jr. announced in a press release that he has directed the Food and Drug Administration (FDA) to explore rulemaking to implement a...more
It remains unclear the extent to which the order will impact agencies like FDA.
On February 11, 2025, as part of an ongoing effort to reduce the size of the federal workforce, President Trump issued an executive order titled...more
The final guidance describes FDA’s enforcement discretion policy for sharing scientific information on unapproved uses of approved products and suggests a safe harbor for sharing off-label information consistent with the...more
1/16/2025
/ Compliance ,
Data-Sharing ,
Enforcement ,
Final Guidance ,
Final Rules ,
Food and Drug Administration (FDA) ,
Life Sciences ,
Off-Label Use ,
Pharmaceutical Industry ,
Prescription Drugs ,
Regulatory Authority ,
Regulatory Requirements ,
Risk Management ,
Safe Harbors
FDA will hold a webinar regarding the proposed rule, which reiterates FDA’s assertion of jurisdiction over laboratory developed tests and proposes a phaseout of its general enforcement discretion approach.
On October 31,...more