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.
Federal Register notice: FDA makes available a draft guidance entitled Uncomplicated Urinary Tract Infections: Developing Drugs for Treatment.
FDA asks drug applicants to use SNOMED CT to characterize disease names for product indications.
FDA approves an Astellas Pharma supplemental NDA that seeks approval for the use of mirabegron in combination with solifenacin succinate 5 mg for trea...
A Tufts Center for the Study of Drug Development analysis shows that development time for orphan drugs is significantly longer than for all new drugs ...
FDA issues a question-and-answer document on microsampling as part of the assessment of systemic exposure in toxicity studies.