Insight on Veklury’s clinical and strategic pathway for USFDA approval for Covid-19
Posted on24 Oct 2020
TagsCOVID-19, priority review, Priority Review Designation, Remdesivir, usfda, usfda accelerated approval, USFDA Priority Review, Veklury
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USFDA approved the antiviral drug Veklury (remdesivir) for use in adult and pediatric patients 12 years of age and older and weighing at... Read More
What is CRL – Complete Response Letter by USFDA?
Complete response letter is issued by USFDA to new drug / abbreviated application holder, if they determines that we will not approve... Read More
Case Study: USFDA approval of Exeltis’s Slynd, an oral contraceptive tablet
Exeltis USA, Inc. a division of the global pharmaceutical group Insud Pharma, announced that the US Food and Drug Administration (FDA) has... Read More
Luye Pharma’s Rykindo NDA Filing Accepted by the US FDA
Rykindo, Luye Pharma’s innovative, independently developed Extended-Release Microspheres formulation for injection, is one step closer to going on the U.S. market. The... Read More
FDA approves new treatments for heart disease caused by a serious rare disease, transthyretin mediated amyloidosis
U.S. Food and Drug Administration approved Vyndaqel (tafamidis meglumine) and Vyndamax (tafamidis) capsules for the treatment of the heart disease (cardiomyopathy) caused... Read More
Can a new drug rejected by USFDA, can get EU approval?
Yes it can be. US and EU regulatory body work independently, without any influence of each other. Review of the new drug... Read More
What is USFDA – Field Alert Report (FAR) Submission for NDAs and ANDAs?
Posted on31 Jul 2018
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FAR – Field Alert Report Submission FAR should be submitted using Form FDA 3331a. This is for applicants of new drug applications... Read More