FDA Related News

Human Drugs

FTC Hits First iV Cocktails Seller

The FDA charges A & O Enterprises, a seller of intravenously injected therapy products (iV Cocktails), with making a range of deceptive and unsupporte...

Human Drugs

Vita Medical Spray-on Skin Cells Approved for Burns

FDA approves a Vita Medical PMA for the Recell Autologous Cell Harvesting Device for treating severe thermal burns in patients 18 years and older.

Human Drugs

MicuRx Gains Fast Track for Antibiotics

FDA grants MicuRx Pharmaceuticals fast track status and a qualified infectious disease product desgination for contezolid (MRX-I) and its prodrug cont...

Federal Register

Draft Guide on Clinicaltrials.com Money Penalties

Federal Register notice: FDA makes available a draft guidance entitled Civil Money Penalties Relating to the ClinicalTrials.gov Data Bank; Draft Guida...

Human Drugs

11 Observations on Zhejiang Huahai FDA-483

FDA releases an FDA-483 with 11 observations from an inspection at Chinas Zhejiang Huahai Pharmaceutical Co.

Human Drugs

3 Observations in Strides Pharma Science Inspection

FDA completes a pre-approval product inspection at Indias Strides Pharma Sciences with three inspection observations.

Human Drugs

OBI Pharma Granted Orphan Status for Leukemia Drug

FDA grants OBI Pharma an orphan drug designation for OBI-3424 for treating acute lymphoblastic leukemia.

Federal Register

Q&A Guide on Product Identifiers

Federal Register notice: FDA makes available a draft guidance entitled Product Identifiers Under the Drug Supply Chain Security Act Questions and Answ...

Clinical Trials Penalties Guidance

FDA describes its approach to seeking civil money penalties from those failing to follow ClinicalTrials.gov submission requirements and FDA certificat...

Human Drugs

FDA Mulls New Drug Shortage Authority: Woodcock

CDER director Janet Woodcock says the agency is considering whether it has new authorities available under FDASIA it can use to address drug shortages...