The US Food and Drug Administration (FDA)’s recently issued final rule establishing application, labeling, and postmarketing reporting requirements for a nonprescription drug product with an “additional condition for...more
1/17/2025
/ Final Rules ,
Food and Drug Administration (FDA) ,
Healthcare ,
New Regulations ,
Over The Counter Drugs (OTC) ,
Pharmaceutical Industry ,
Prescription Drugs ,
Product Labels ,
Public Health ,
Regulatory Requirements ,
Reporting Requirements
The Drug Supply Chain Security Act (DSCSA) (section 582 of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 USC §360eee – 1) was introduced in response to several drug contamination, counterfeiting, and diversion...more
1/14/2025
/ Deadlines ,
Drug Distribution ,
DSCSA ,
Enforcement Actions ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Final Rules ,
Food & Drug Regulations ,
Food and Drug Administration (FDA) ,
Life Sciences ,
Pharmaceutical Industry ,
Prescription Drugs ,
Regulatory Requirements ,
Supply Chain