Federal Register notice: FDA asks for comments on an information collection extension for electronic drug product reporting for human drug compounding...
FDA releases a draft guidance describing how sponsors must organize content submitted electronically to the agency.
FDA issues a safety alert about potential complications in patients implanted with both programmable cerebrospinal fluid shunt systems and some hearin...
FDA warns Ecometics about repeat CGMP violations in its work as a contract manufacturer of OTC and Rx drugs.
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.