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Federal Register Notice: FDA releases a guidance: Microbiology Data for Systemic Antibacterial Drugs Development, Analysis, and P...[ Price : $8.95]
Illinois attorney general Lisa Madigan files a lawsuit against Insys Therapeutics for deceptively marketing and selling Subsys, a ...[ Price : $8.95]
FDA grants Mallinckrodt a fast track designation for Synacthen Depot (tetracosactide) and its use in treating Duchenne muscular dy...[ Price : $8.95]
FDA grants Biotie Therapies an orphan drug designation for its BTT1023 drug candidate for treating primary sclerosing cholangitis,...[ Price : $8.95]
FDA grants Lupin Ltd. tentative approval for its ANDA for paroxetine extended-release tablets, 12.5 mg, 25mg and 37.5 mg, generic ...[ Price : $8.95]
CDRH says it is creating a new Pediatric Extrapolation for Devices team to evaluate and review device submissions that include dat...[ Price : $8.95]
FujiFilm Medical Systems files the final PMA module for its digital breast tomosynthesis, an optional software upgrade for the Asp...[ Price : $8.95]
BIO issues guiding principles for interactions between it and its members and patient advocacy organizations.