FDA approves an Ortho Dermatologics NDA for Altreno (tretinoin 0.05%) lotion, indicated for the topical treatment of acne vulgaris in patients nine ye...
Federal Register notice: FDA seeks comments on an information collection extension entitled Prescription Drug User Fee Cover Sheet; Form FDA 3397.
The Senate passes a bipartisan amendment introduced by Sens. Chuck Grassley (R-IA) and Dick Durbin (D-IL) requiring pharmaceutical companies to list p...
FDA grants Dthera Sciences a breakthrough device designation, for its Alzheimers treatment, DTHR-ALZ.
FDA releases a report summarizing its 4/16 public workshop on clinical trial inclusion and exclusion.
Federal Register notice: FDA seeks comments on an information collection extension entitled Sun Protection Factor Labeling and Testing Requirements fo...
Federal Register notice: FDA makes available a draft guidance entitled Osteoarthritis: Structural Endpoints for the Development of Drugs, Devices, and...
Federal Register notice: FDA requests nominations for voting members to serve on the Device Good Manufacturing Practice Advisory Committee and device ...