[ Price : $8.95]
FDA cites AGC Biologics for deficiencies in laboratory data controls and inventory management at its Bothell, WA, drug substance m...[ Price : $8.95]
FDA accepts for review a Biofrontera supplemental NDA seeking to expand the label of its photodynamic therapy drug Ameluz (aminole...[ Price : $8.95]
FDA posts a draft guidance entitled Certification Process for Designated Medical Gases.[ Price : $8.95]
The CDER Office of Prescription Drug Promotion cautions Janssen Biotech about a direct-to-consumer TV ad for Tremfya that misleadi...[ Price : $8.95]
A Washington Post opinion article takes issue with FDAs recent decision to reject a low-dose atropine treatment for pediatric myop...[ Price : $8.95]
FDA moves to blunt criticism of the Commissioners National Priority Voucher Program with a news release containing 18 questions an...[ Price : $8.95]
FDA warns Mark Dacey of Denver, CO, about failing to obtain informed consent for two clinical investigations he conducted.[ Price : $8.95]
FDA and industry representatives report agreement on several issues in the 1/21 MDUFA 6 negotiating session.