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Core Patient-Reported Outcomes in Cancer Clinical Trials - USFDA
This is a DRAFT GUIDANCE distributed for comment purposes only. This guidance provides recommendations to sponsors for the collection of...
Sharan Murugan
Jun 19, 20211 min read
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FDA’s New Draft Guidances on Device Postmarket Surveillance – For Comments
The US Food and Drug Administration (FDA) has issued draft guidance to help Medical Device Manufacturers comply with postmarket...
Sharan Murugan
Jun 11, 20211 min read
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FDA Guidance regarding Onsite Inspections during COVID19 (Q&A) - USA
After the publication of the Guidance for "Remote Interactive Evaluations", FDA has updated its "Manufacturing, Supply Chain, and Drug...
Sharan Murugan
May 28, 20211 min read
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ANDAs for Certain Highly Purified Synthetic Peptide Drug Products
The guidance is intended to assist potential applicants in determining when an application for a synthetic peptide drug product...
Sharan Murugan
May 28, 20211 min read
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FDA Offers guidance on Generic Drug Development- COVID
US Food and Drug Administration (FDA) On April-5, 2021 released new questions and answers guidance for generic drug makers briefing...
Sharan Murugan
May 4, 20211 min read
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