FDA Leadership Profiles | FDA
Bios of U.S. Food and Drug Administration leadership
Center for Biologics Evaluation and Research (CBER) | FDA
2024年9月18日 · CBER is the Center within FDA that regulates biological products for human use under applicable federal laws, including the Public Health Service Act and the Federal Food, …
Bioresearch Monitoring Program Information | FDA
2022年8月4日 · FDA's Bioresearch Monitoring (BIMO) program is a comprehensive program of on-site inspections, data audits, and remote regulatory assessments designed to monitor all …
BIO Statement on Resignation of Peter Marks from the FDA
19 小时之前 · John Crowley, President and CEO of the Biotechnology Innovation Organization (BIO), released the following statement regarding the resignation of Peter Marks from the …
BIO celebrates release of FDA Rare Disease Innovation Hub 2025 ...
2025年2月20日 · The FDA heeded BIO’s recommendation, citing one of its goals as “further advancing regulatory science of rare disease therapies.” “The [Hub] will design and implement …
FDA approves first-of-its-kind RNA drug for hemophilia
21 小时之前 · FDA approves first-of-its-kind RNA drug for hemophilia The Sanofi drug, known as fitusiran and now Qfitlia, was approved on Friday for a broad group of people with the rare …
BIO Statement on EPA/FDA/USDA Release of Plans for Reforming …
2024年5月8日 · “BIO is pleased to see today’s report released by EPA, FDA and USDA outlining the joint plan for regulatory reform under the Coordinated Framework for Regulation of …
EPA, FDA, and USDA release plan to improve biotech regulation - Bio…
2024年5月10日 · Several federal agencies on May 8 announced a plan to coordinate and streamline regulation of plants, animals, and microorganisms modified through biotechnology. …
FDA Approvals of Biologics in 2022 - PMC
Monoclonal antibodies (mAbs) continued to be the drug class with the most approvals, and cancer remained the most targeted disease, followed by autoimmune conditions, as in previous years. …
FDA’s Regulation of Plant and Animal Biotechnology Products
2024年12月16日 · The FDA regulates plant and animal biotechnology products in coordination with the U.S. Department of Agriculture (USDA) and U.S. Environmental Protection Agency …