[ Price : $8.95]
FDA grants MicuRx Pharmaceuticals fast track status and a qualified infectious disease product desgination for contezolid (MRX-I) ...[ Price : $8.95]
Federal Register notice: FDA makes available a draft guidance entitled Civil Money Penalties Relating to the ClinicalTrials.gov Da...[ Price : $8.95]
FDA releases an FDA-483 with 11 observations from an inspection at Chinas Zhejiang Huahai Pharmaceutical Co.[ Price : $8.95]
FDA completes a pre-approval product inspection at Indias Strides Pharma Sciences with three inspection observations.[ Price : $8.95]
FDA grants OBI Pharma an orphan drug designation for OBI-3424 for treating acute lymphoblastic leukemia.[ Price : $8.95]
Federal Register notice: FDA makes available a draft guidance entitled Product Identifiers Under the Drug Supply Chain Security Ac...[ Price : $8.95]
FDA describes its approach to seeking civil money penalties from those failing to follow ClinicalTrials.gov submission requirement...[ Price : $8.95]
CDER director Janet Woodcock says the agency is considering whether it has new authorities available under FDASIA it can use to ad...