FDA Review post the Federal Register notices for the week ending 8/24/2018.
FDA Review posts product approval summaries for the week ending 8/3/2018.
Federal Register notice: CDER announces the Fiscal Year 2019 CDER Office of Pharmaceutical Quality (OPQ) Staff Experiential Learning Site Visit Progra...
Federal Register notice: FDA determines that Plasma Lyte M And Dextrose 5% and Plasma Lyte and Dextrose 5% were not withdrawn for reasons of safety o...
Federal Register notice: FDA makes available a draft guidance entitled Hematologic Malignancy and Oncologic Disease: Considerations for Use of Placebo...
The U.S. Court of Appeals for the Seventh Circuit reverses a lower court decision and $3 million verdict in a product liability that attempted to hold...
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.