FDA publishes an International Pharmaceutical Regulators Program reflection paper addressing general considerations for using raw materials in the man...
The Senate Appropriations Committee announces a 4/19 subcommittee hearing to review FDAs fiscal year 2024 budget request.
An FDA Advisory Committee votes 16 to 1 that Pfizers Paxlovid (nirmatrelvir and ritonavir) has a favorable benefit-risk profile for treating mild-to-m...
FDA commissioner Robert Califf calls on health insurers to play a role in seeing that confirmatory trials are completed for drugs approved through the...
FDA publishes a draft guidance on using electronic systems, records, and signatures in clinical investigations of some regulated products.
FDA modifies a partial clinical hold against Stoke Therapeutics to allow the administration of a higher single dose of STK-001 (70 mg) in its ongoing ...
Federal Register notice: FDA seeks comments on an information collection extension entitled Radioactive Drug Research Committees 21 CFR 361.1.
Federal Register notice: FDA withdraws approval of six ANDAs from multiple applicants after they notified the agency that the products are no longer m...
