FDA’s two-part strategy for reining in DTC advertisements involves greater enforcement combined with rulemaking to require more risk information in broadcast advertisements....more
9/25/2025
/ Advertising ,
Artificial Intelligence ,
Department of Health and Human Services (HHS) ,
Direct to Consumer Sales ,
Enforcement Actions ,
False Advertising ,
FDA Warning Letters ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Food and Drug Administration (FDA) ,
Labeling ,
Pharmaceutical Industry ,
Popular ,
Prescription Drugs ,
Product Labels ,
Proposed Rules ,
Television Commercials
On September 4, 2025, the US Food and Drug Administration (FDA or the Agency) announced that it released a second batch of complete response letters (CRLs) — which explain the Agency’s determination for refusing to approve a...more
FDA issued a draft guidance that lays the groundwork for drug companies to comply with changes to approved color additives....more
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 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
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