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.
Four stakeholders voice support for an FDA proposal to reclassify surgical staplers and staples for internal use from Class 1 to Class 2 with special ...
FDA approves Teva Pharmaceutical Industries AirDuo Digihaler (fluticasone propionate 113 mcg and salmeterol 14 mcg) Inhalation Powder, a combination t...
FDA announces two innovation challenges to encourage new approaches for sterilizing medical devices.