WebApr 14, 2024 · Vertex Pharma and CRISPR Therapeutics are the first companies to seek FDA clearance for a gene-editing therapy. Vertex Pharmaceuticals and CRISPR Therapeutics have gotten closer to introducing exagamglogene autotemcel (exa-cel), a one-time treatment for sickle cell disease (SCD) and transfusion-dependent beta-thalassemia … WebJul 30, 2024 · The Insight Time Reporting (ITR) system is an agency-wide project to modernize FDA ’s activity-based time reporting capabilities, enabling the collection of …
What does FDA inspect? FDA - U.S. Food and Drug Administration
WebApr 10, 2024 · WASHINGTON, April 10 (Reuters) - The U.S. government on Monday appealed a Texas judge's decision to suspend the Food and Drug Administration's 23-year-old approval of a key abortion drug, saying... Web2 days ago · The abortion opponents' requests came one day after the U.S. Department of Justice urged the appeals court to put U.S. District Judge Matthew Kacsmaryk's April 7 order voiding the FDA's approval ... make a scarf dress
Appeals court revives FDA approval of mifepristone but with limits
WebJan 19, 2024 · Join FDA leaders as they provide their insight into issues facing the agency – including the COVID-19 pandemic and other emerging topics. The program will be on … WebJun 10, 2024 · Medtech Insight sat down with O’Leary on 9 June to ask him about his new role at the DHCOE, the big shoes he’ll have to fill now that Patel is gone, the need for new regulatory frameworks for digital health, what he hopes to accomplish as acting head of the DHCOE – and more. The Q&A below has been lightly edited for content and clarity. WebOct 12, 2024 · THURSDAY, 15 OCTOBER. 9:00 a.m. – 10:30 a.m. P7: Complex Generic Combination Products. Moderator: Lee Leichter, P/L Biomedical. To be approved as a generic drug, suitable for substitution for the reference listed drug (RLD), the FDA requires the demonstration of a legal concept of “sameness”. make a scatter graph