FDA resumes posting complete response letters just days after HHS confirmed that new rejection letter releases had been halted temporarily while the agency reviewed legal and policy concerns surrounding its controversial transparency initiative.
FDA proposed a rule seeks to modernize drug establishment registration requirements by creating a streamlined pathway for distributed manufacturing facilities and clarifying registration obligations for certain foreign drug manufacturers.
FDA resumes posting complete response letters just days after HHS confirmed that new rejection letter releases had been halted temporarily while the agency reviewed legal and policy concerns surrounding its controversial transparency initiative.
FDA proposed a rule seeks to modernize drug establishment registration requirements by creating a streamlined pathway for distributed manufacturing facilities and clarifying registration obligations for certain foreign drug manufacturers.
FDA sends Hengrui Pharma and Elevar Therapeutics a third complete response letter for their combination of camrelizumab and rivoceranib for first-line treatment of unresectable or metastatic hepatocellular carcinoma.
An FDA inspection of SGS North America's contract testing laboratory identifies significant concerns with the firm’s laboratory controls, including a failure to adequately verify reference standards used to test pharmaceutical products.
