FDA Leadership Profiles | FDA - U.S. Food and Drug Administration
FDA Modernization Efforts for Establishing a Unified Human Foods Program, New Model for Field Operations and More; FDA Organization Charts
U.S. Food and Drug Administration
The FDA is responsible for protecting the public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices; and by …
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, …
BIO Statement on Resignation of Peter Marks from the FDA
3 天之前 · John Crowley, President and CEO of the Biotechnology Innovation Organization (BIO), released the following statement regarding the resignation of Peter Marks from the FDA: …
FDA Approvals & Clinical Development Pipeline - BIO
Join BIO as we champion for bringing new treatments to patients with serious medical conditions and to support policies that promote innovation and improve patient access.
详解|FDA生物制品的申报许可流程及要求 - 健康界
2022年7月8日 · fda认为新药的申请应具备明确的研究目的、恰当的试验设计、确切定义患者对治疗反应的评价方法、有科学依据的患者筛选方法以及具备适当的措施能够将偏向性减到最小， …
BioPreferred
Federal law, the Federal Acquisition Regulation, and Presidential Executive Orders direct federal agencies and their contractors to purchase biobased products in categories identified by …
EPA, FDA, and USDA Issue Joint Regulatory Plan for Biotechnology
2024年5月8日 · It describes the comprehensive federal regulatory policy for ensuring the safety of biotechnology products, including how EPA, the FDA, and USDA share responsibility for …
FDA Approvals of Biologics in 2022 - PMC - PubMed Central (PMC)
We highlight new drugs and their efficacy, mechanisms, and targets, and compare them to the Biologics already on the market. We also undertake a quantitative and qualitative analysis of …
Fresh from the biotech pipeline: FDA approvals settle in 2024
2025年1月20日 · Almost two-thirds of the 54 new therapies and vaccines indeed emerged from biotech, rather than Big Pharma, pipelines, marking a shift from 2023 and highlighting …