FDA releases a Form FDA-483 with seven observations from an inspection at Koreas Hugel drug substance and drug product manufacturing facility.
FDA publishes a draft guidance on general clinical pharmacology considerations for pediatric studies of drugs, including biologics.
Philips Respironics recalls 17 million masks used with bilevel positive airway pressure machines and continuous positive airway pressure machines due ...
Federal Register notice: FDA announces a 10/6 advisory committee meeting to discuss a Veru Inc. request for an emergency use authorization for tubulin...
Federal Register notice: FDA announces that a product was approved using a priority review voucher Genentechs Vabysmo (faricimab-svoa).
CDER and CBER accept the first letter of intent submission for the new Innovative Science and Technology Approaches for New Drugs pilot program to dev...
After reporting new clinical trial data, Ionis Pharmaceuticals and AstraZeneca plan to submit an NDA for eplontersen for treating patients with heredi...
Four drug industry stakeholders ask FDA to clarify elements in a draft guidance on interoperable exchange of information under the Drug Supply Chain S...
