Tag Archive
The following is a list of all entries tagged with drug regulations:
Drug Regulators, FDA New Draft Guidance
Filed in clinical, marketing, regulatory, August 4, 2009, 9:21 amThe FDA has published new draft guidance, Postmarketing Studies and Clinical Trials — Implementation of Section 505(o) of the Federal Food, Drug, and Cosmetic Act
Drug Regulations – FDA Labeling for Susceptibility Test in Systemic Antibacterial Drug Products
Filed in labeling, regulatory, July 15, 2009, 3:40 pmThe FDA has published guidance on “Updating Labeling for Susceptibility Test Information in Systemic Antibacterial Drug Products and Antimicrobial Susceptibility Testing Devices. The purpose of this guidance is to inform industry of how the FDA intends to comply with section 1111 of the Food and Drug Administration Amendments Act (FDAAA), which requires FDA to identify and periodically update susceptibility test interpretive criteria for antibacterial drug products and to make those findings publicly available
Drug Development Regulations and Guidance from EMEA – Clinical Evaluation of Antifugals
Filed in clinical, regulatory, July 2, 2009, 10:45 amDrug development regulations and guidance from the EMEA has been published in draft for comment on Clinical Evaluation of Antifungals
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