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Over the past week, the FDA issued final guidance for waivers, exceptions, and exemptions from Section 582 of the FD&C Act, draft guidance for previously approved antiretrovirals for treatment of HIV, and modifications to the list of recognized consensus standards. Read More
Upcoming events in the coming weeks include six FDA advisory committee meetings, the GMP Quality Management vSummit and webinars from FDAnews, a WCG company on reliability assessment and medical device risk management tools. Read More
As the 118th Congress continues, FDAnews will track important pending legislation to keep you updated on regulations that could impact your business. Read More
Over the past week, the FDA issued final guidance for deoxyribonucleic acid (DNA) reactive impurities in pharmaceuticals, assessing biosimilar user fees, hydrogen peroxide-based contact lens products and CDER’s program for the recognition of voluntary consensus standards guidance on medical device development tools. The FDA 2024 user fees were also announced. Read More
Upcoming events in the coming weeks include six FDA advisory committee meetings as well as the GMP Quality Management vSummit, and webinars from FDAnews, a WCG company on reliability assessment and medical device risk management tools. Read More
As the 118th Congress continues, FDAnews will track important pending legislation to keep you updated on regulations that could impact your business. Read More
Upcoming events in the coming weeks include five FDA advisory committee meetings as well as the GMP Quality Management vSummit, and webinars from FDAnews, a WCG company on reliability assessment and medical device risk management tools. Read More
As the 118th Congress continues, FDAnews will track important pending legislation to keep you updated on regulations that could impact your business. Read More
Over the past week, the FDA has issued draft guidances on inborn errors of metabolism, clinical trial postmarketing studies and human cellular and gene therapy products. Read More
Upcoming events in the coming weeks include five FDA advisory committee meetings as well as the WCG MAGI Clinical Research Conference and a webinar from FDAnews, a WCG company on design control. Read More
As the 118th Congress continues, FDAnews will track important pending legislation to keep you updated on regulations that could impact your business. Read More