Rep. Mike Kelly asks FDA for information on why the agency failed to include insulin in a 2017 ANDA guidance on peptide drug products.
Stakeholders ask for additional information in FDA covariate guidance.
FDA releases its latest batch of Warning Letters that includes Ecometics and Strides Pharma Science.
FDA publishes an ICH guideline on optimization of safety data collection.
FDA accepts for priority review a Novartis BLA for its investigational sickle cell drug crizanlizumab for preventing vaso-occlusive crises.
FDA announces two innovation challenges to encourage new approaches for sterilizing medical devices.
Federal Register notice: FDA seeks comments on an information collection extension for its Guidance for Industry on Hypertension Indication: Drug Labe...
Federal Register notice: FDA determines that Novartis Miochol (acetylcholine chloride intraocular solution) was not withdrawn from sale due to safety ...