美国FDA 指导原则 ANDA提交-GDUFA行业指导下的事先批准补充材料 英文原版.pdf,ANDA Submissions – Prior Approval Supplements Under GDUFA Guidance for Industry U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluatio
ingentaconnectGray Sheet
On Monday, the FDA published “Catching Up with Califf: FDA’s Dietary Supplements Program Remains a Critical Priority,” by Robert M. Califf, M.D., Commissioner of Food and Drugs. The FDA is embarking on an ambitious plan to transform the current...
LITFULO is the first and only treatment for severe alopecia areata approved for patients as young as 12 Pfizer Inc. (NYSE: PFE) announced today that the U.S. Food and Drug Administration (FDA) has approved LITFULO ™ (ritlecitinib), a once-daily oral t
【美国FDA对膳食补充剂(Dietary Supplements)大多是按照普通食品进行管理的，以确保产品安全、完善，标识...
Zepbound is the first and only approved treatment activating two incretin hormone receptors, GIP and GLP-1, to tackle an underlying cause of excess weight INDIANAPOLIS,Nov. 8, 2023/PRNewswire/ -- TheU.S. Food and Drug Administration(FDA) approvedEli Lilly and Company's(NYSE:...
ATLANTA,Oct. 17, 2023/PRNewswire/ -- UCB (Euronext Brussels: UCB), a global biopharmaceutical company, today announced thatZilbrysq®(zilucoplan) has been approved by the U.S. Food and Drug Administration (FDA) for the treatment of generalized myasthenia gravis (gMG) in adult patients ...
比如各类出口认证。以题主所提到的食品（food）、药品（drugs）以及dietary supplements为例，其实FDA都不...
Food and Drug Administration (FDA) has approved Duvyzat™ (givinostat), a novel histone deacetylase (HDAC) inhibitor, for the treatment of patients 6 years or older with Duchenne muscular dystrophy (DMD), a rare X-linked progressive and life-limiting neuromuscular condition with symptoms from ...
June 28, 2023-- Today, the U.S. Food and Drug Administration approved Lantidra, the first allogeneic (donor) pancreatic islet cellular therapy made from deceased donor pancreatic cells for the treatment of type 1 diabetes. Lantidra is approved for the treatment of adults with type 1 diabetes...