On March 10, the U.S. Department of Health and Human Services (HHS) issued a press release emphasizing “radical transparency to make sure all Americans know what is in their food” and announcing that HHS Secretary Robert F....more
On January 6, 2024, the U.S. Food and Drug Administration (FDA) issued its final guidance establishing action levels for lead in processed food intended for babies and young children. This is the first FDA guidance directly...more
1/13/2025
/ Baby Products ,
Class Action ,
Compliance ,
Consumer Protection Laws ,
Enforcement Actions ,
Final Rules ,
Food and Drug Administration (FDA) ,
Food Safety ,
Lead ,
Liability ,
Manufacturers ,
Product Defects ,
Public Health ,
Regulatory Requirements ,
Risk Mitigation ,
Toxic Chemicals
In the latest attempt to promote generic drug competition and reduce drug prices, and consistent with broader efforts to enforce the antitrust laws more aggressively, the Federal Trade Commission (FTC) announced on November...more
11/14/2023
/ Antitrust Division ,
Competition ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Federal Trade Commission (FTC) ,
Food and Drug Administration (FDA) ,
FTC Act ,
Generic Drugs ,
Hatch-Waxman ,
Manufacturers ,
Orange Book ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Policy Statement
The Modernization of Cosmetics Regulation Act of 2022 (MoCRA) was passed by the U.S. Congress as part of the omnibus Consolidated Appropriations Act enacted on December 29, 2022 and will grant the U.S. Food and Drug...more
1/13/2023
/ Adverse Events ,
Consolidated Appropriations Act (CAA) ,
Cosmetics ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Food and Drug Administration (FDA) ,
Labeling ,
Manufacturers ,
Policies and Procedures ,
Public Safety ,
Recordkeeping Requirements ,
Registration Requirement
If you are a device manufacturer, what human factors and usability information should you include in your marketing submission? What if your device has the same user interface as an existing device?...more
On September 30, 2021, the U.S. Food and Drug Administration (FDA) announced final guidance titled “Interpreting Sameness of Gene Therapy Products under the Orphan Drug Regulations.” The guidance finalizes the January 2020...more