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Sharan Murugan
- Dec 23, 2021
- 2 min
First Oral Antiviral (PFIZER) for Treatment of COVID-19 -USFDA
Yesterday U.S. Food and Drug Administration issued an emergency use authorization (EUA) for Pfizer’s Paxlovid (nirmatrelvir tablets and...
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Sharan Murugan
- Dec 18, 2021
- 1 min
Unannounced Inspections in India And China to be Resumed Soon: USFDA
Senior US Senator Chuck Grassley has urged to "reinstate unannounced" inspections of prescription drug manufacturing facilities in...
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Sharan Murugan
- Dec 5, 2021
- 1 min
USFDA publishes FY 2022 GDUFA Science & Research Priority Initiatives & FY 2022 collaboration
On December 2,2021 the U.S. (FDA) published the Fiscal Year (FY) 2022 Generic Drug User Fee Amendments (GDUFA) Science and Research...
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Sharan Murugan
- Nov 7, 2021
- 1 min
Knowledge aided Assessment and Structured Application (KASA) Initiative
The current challenges with the eCTD system that the agency currently uses, explaining how it does “not follow the development flow of...
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Sharan Murugan
- Sep 8, 2021
- 1 min
USFDA's Novel Excipient Review Pilot Program
The Center for Drug Evaluation and Research (CDER) has launched the voluntary Novel Excipient Review Pilot Program (Pilot Program), which...
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