Federal Register notice: FDA determines that GE Healthcares sodium iodide I 123 oral solution, 2 millicuries/milliliter was not withdrawn from sale du...
FDA posts a draft guide on Pediatric HIV Infection: Drug Development for Treatment that provides general recommendations on developing drug products f...
FDA issues a guidance answering questions about how it defines a drug outsourcing facility.
FDA and Oncolytics Biotech agree on a special protocol assessment for a Phase 3 trial of the companys Reolysin to treat metastatic breast cancer.
FDA files two federal court complaints seeking permanent injunctions to stop two stem cell clinics from marketing stem cell products without FDA appro...
Federal Register notice. FDA makes available a guidance entitled S3A Guidance: Note for Guidance on Toxicokinetics: The Assessment of Systemic Exposur...
FDA denies without comment a Mylan petition asking it to impose conditions on approval of any ANDA citing Advair Diskus as the reference-listed drug.
FDA grants Sellas Life Sciences Group an orphan drug designation for its novel drug candidate, galinpepimut-S, for treating multiple myeloma.