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Sharan Murugan
- Aug 4, 2023
- 2 min
USFDA Guidance: Waivers, Exceptions, & Exemptions from Section 582 of FD&C Act
Today (04 August 2023) the United States Food & Drug Administration's Center for Biologics Evaluation and Research and Center for Drug...
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Sharan Murugan
- Apr 10, 2022
- 1 min
FDA's Draft Guidance on Cybersecurity in MD: Quality System Consideration & Content of Premarket Sub
This draft guidance document is being distributed for comment purposes only. Cybersecurity incidents have rendered medical devices and...
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Sharan Murugan
- Sep 14, 2021
- 2 min
USFDA’s Study Data Technical Conformance Guide & Technical Specifications Doc Update -USA
Study Data Technical Conformance Guide provides specifications, recommendations, and general considerations on how to submit standardized...
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Sharan Murugan
- Sep 11, 2021
- 1 min
USFDA's updated guidance on Development of ANDA During the COVID-19 Pandemic – Q&A -USA
On 8th September 2021, FDA issued this guidance to provide general recommendations to prospective applicants and applicants 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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