USA – FDA expands KASA review program to drug substances
The US Food and Drug Administration (FDA) is now piloting its Knowledge-aided Assessment and Structured Application (KASA) drug review program for drug substances as...
USA – FDA finalizes guidance on standards for tracing products through supply chain
The US Food and Drug Administration (FDA) will allow trading partners to track drug products through the pharmaceutical supply chain using portals and email...
USA – FDA investigates risk of secondary malignancies with CAR T-cell therapy
The US Food and Drug Administration (FDA) is investigating reports of a “serious risk” of T-cell malignancies linked to treatment with chimeric antigen receptor...
USA – FDA Approves Prescription Nasal Spray to Reverse Opioid Overdose
Today, the U.S. Food and Drug Administration approved Opvee, the first nalmefene hydrochloride nasal spray for the emergency treatment of known or suspected opioid...
USA – Biosimilar facilities usually get onsite inspections
A US Food and Drug Administration (FDA) official said that sites making biosimilars will be inspected in person, as opposed to virtual methods, as...
USA – FDA relaxes EUA advertising limitation for some COVID drugs
The US Food and Drug Administration (FDA) has relaxed a limitation on advertising and promotion for certain COVID-19 drugs with emergency use authorizations (EUAs)....
USA – QMSR: Start now to be ready for final rule, slated for December
The US Food and Drug Administration (FDA) asserts that it is on track to release a final rule this December that harmonizes the agency’s decades-old Quality...
USA – FDA issues final guidance on rare disease drug development
The US Food and Drug Administration (FDA) finalized guidance on drug development programs for rare diseases, eliminating a section on natural history and providing...
USA – FDA issues new standards for DTC prescription drug ads
The US Food and Drug Administration (FDA) published its final rule changing how companies must present the “major statement” in direct-to-consumer (DTC) TV and...
USA – FDA issues emergency guidance to spur development of monkeypox tests
The US Food and Drug Administration (FDA) issued an immediately effective guidance and a corresponding FAQ to spur the development of new monkeypox diagnostics...
