FDA releases an FDA-483 issued to Indias Ipca Laboratories with three inspection observations.
The Federal Trade Commission warns three companies that they need credible and reliable scientific evidence to make health claims for CBD-infused prod...
The Metrix Co. (Dubuque, IA) recalls several lots of its empty IV flexible containers due to the potential for leakages from the IV bag at the chamber...
Federal Register notice: FDA submits to OMB an information collection extension for Medical Devices; Use of Symbols in Labeling Glossary To Support t...
FDA warns South Koreas Enprani Co. about CGMP and other violations in its manufacturing of finished pharmaceuticals.
CluePoints and FDA extend their cooperative research and development agreement that is exploring a data-driven approach to selecting clinical trial si...
Federal Register notice: FDA withdraws approval of 25 NDAs from multiple applicants after they notified the agency that the drug products were no long...
Federal Register notice: FDA makes available a final guidance entitled Acceptance Review for De Novo Classification Requests.