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FDA announces a 1/26 virtual workshop on non-clinical assays for comparative immunogenicity risk assessment for generic peptide pr...[ Price : $8.95]
FDA commissioner Stephen Hahn says the agency is posting scientific review materials relating to emergency use authorization actio...[ Price : $8.95]
PhRMA adds a chapter on diversity to its principles for conducting and communicating clinical trials.[ Price : $8.95]
FDA posts new drug safety-related labeling changes for five biologics.[ Price : $8.95]
FDA warns Family Pharmacy of Statesville, NC, about multiple drug compounding violations.[ Price : $8.95]
FDA issues a final guidance on Certificates of Confidentiality, which describes the agencys implementation of revised provisions u...[ Price : $8.95]
Alkermes says it is working with FDA on issues raised in an agency complete response letter for the firms NDA for ALKS 3831 to tre...[ Price : $8.95]
CDER deputy Center director for clinical science Bob Temple opines on meetings with industry on product development issues that ma...