[ Price : $8.95]
FDA publishes a draft guidance to assist ANDA applicants in demonstrating the bioequivalence of topical corticosteroids.[ Price : $8.95]
FDA approves a new indication for Servier Pharmaceuticals Tibsovo to treat adults with some myelodysplastic syndromes as detected ...[ Price : $8.95]
FDA releases the form FDA-483 with four observations from an inspection at Switzerlands UCB Farchim drug manufacturing facility.[ Price : $8.95]
Hyman, Phelps & McNamara attorney Dara Levy says FDA is taking a new approach to off-label presentations in a new draft guidance.[ Price : $8.95]
ResMed Ltd. recalls its Astral 100 and Astral 150 ventilators due to what FDA calls a device design issue.[ Price : $8.95]
FDA accepts for review an AstraZeneca supplemental BLA that seeks approval for a self- or caregiver-administered option for FluMis...[ Price : $8.95]
Federal Register notice: FDA seeks comments on an information collection extension entitled Export Certificates for FDA Regulated ...[ Price : $8.95]
Federal Register notice: FDA posts a revised draft guidance for industry entitled Communications From Firms to Health Care Provide...