The International Council for Harmonization approves the S12 guidance on nonclinical biodistribution studies for gene therapy products.
The Friends of Cancer Research suggests possible additions to an FDA draft guidance on optimizing the dosage of oncologic drugs.
FDA warns Rogers, AR-based Dunagin Pharmaceuticals, which does business as Massco Dental, about CGMP violations in its manufacturing of finished drugs...
FDA warns Torrance, CA-based Cosmetic Science Laboratories about CGMP and other violations in its production of finished drugs as a contract manufactu...
CBER director Peter Marks tells a Muscular Dystrophy Association conference about ways FDA is addressing barriers to developing gene therapies for rar...
CDER submits a petition outlining its requests if the FDA chief scientist decides to grant Intarcia a hearing on its NDA for drug/device combination I...
Karuna Therapeutics plans a mid-year NDA for schizophrenia drug KarXT (xanomeline-trospium) after reporting positive topline results from a recent Pha...
FDA and RTI International researchers review empirical studies of prescription drug promotion in the last decade and suggest areas for further study.
