When alternateanalyticdlmefhadsthatareequivalentto,c#that areanimprovementover,thecanpndialmetha%are submitted to theagency, theapplicantis encmrag to simultaneamlyask themited States Pharmaccpeial Convention (Us?c) tochangeormdifythemethalology in the mxlosraph. -9- Assay arxI identity ...
美国公众与监管机构对于在亚洲生产的药品质量一直不能放心,近日,FDA发布的关于印度Strides Pharma和印度Indoco Remedies Limited (PlantI)警告信再次说明了问题的严重性。 印度Strides Pharma 检查过程发现被丢弃的CGMP文件和不受控的文件粉碎情况,检查人员在55加仑(约208L)桶中发现了蓝色文件夹,上面有彩色标识显示其来自...
这个警告信是在Sun Pharma回复F483后发布的,这说明FDA对F483的回复报告不满意,这也给广大药企提个醒,回复F483是一个非常重要的事情,好的回复和整改措施有可能会打消FDA的风险顾虑,从而转危为安。 Sun Pharma回复F483的最大问题就是:只针对问题表面进行整改,没有深入分析原因、评估影响、扩大改进。 这些缺陷都是...
Gilead expects to hear from the FDA on a label expansion in the second-line setting in April. SOURCE https://www.fiercepharma.com/pharma/cell-and-gene-therapy-makers-push-past-regulatory-payer-hurdles-to-set-up-high-hopes-for Share this: Click to share on Twitter (Opens in new window) ...
FDA User Fee Act Full of Surprises for Pharma and BiotechPhoebe Mounts, Ph.DKathleen M. Sanzo
The FDA on Friday granted full approval to Seagen and Astellas Pharma's Padcev (enfortumab vedotin-ejfv) in combo with Merck's Keytruda (pembrolizumab) for patients with locally advanced or metastatic urothelial cancer ...
FDA's application of specific criteria to the multisource prescription drug products on the List approved under Section 505 of the Act.These evaluations are presented in the form of code letters that indicate the basis for the e...
“I was watching what was coming through the pipeline,” Mackay said in a recent interview with Fierce Pharma. “I was watching all the new modalities that were at our fingertips—cell therapy, gene therapy, RNA, interference RNA, messenger RNA, neucleotides, gene editing—my tho...
In reversing the district court’s decision on this point, the Eighth Circuit, following a rationale harkening back to the recent decision from the U.S. District Court for the District of New Hampshire in Bartlett v. Mutual Pharma. Co. (see our previous post here), ruled that the ...
This district court ruling provides an excellent guide to use in evaluating some aspects of a pharmace 49、utical laboratory, but should not be considered as law, regulation or binding legal precedent. The court ruled that a firm should have a predetermined testing procedure and it should ...