The US Food and Drug Administration (FDA) recently announced the availability of the first-ever centralized database of Complete Response Letters (CRLs) on openFDA, one of several steps taken under the agency’s initiatives to...more
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