Federal Register notice: FDA withdraws approval of a new animal drug application and two abbreviated new animal drug applications because they are no ...
Federal Register notice: FDA extends until 3/19 the comment period for its draft guidance on Demonstrating Substantial Evidence of Effectiveness for H...
Federal Register notice: FDA makes available a final guidance entitled Hematologic Malignancies: Regulatory Considerations for Use of Minimal Residual...
FDA seeks comments on two proposed studies entitled Endorser Status and Explicitness of Payment in Direct-to-Consumer Promotion.
FDA accepts for review a Corium 505(b)(2) NDA for Adlarity (donepezil transdermal system) for treating Alzheimers-type dementia.
FDA clears a GT Medical Technologies 510(k) for GammaTile Therapy expanded use in surgically targeted radiation therapy in patients with malignant bra...
FDA approves Mercks Dificid (fidaxomicin) oral suspension and tablets for expanded use treating Clostridium difficile infections in children aged six...
FDA posts a draft guidance on Arthroscopy Pump Tubing Sets Intended for Multiple Patient Use - Premarket Notification (510(k)) Submissions.