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USFDA Guidance: Institutional Review Board (IRB) Written Procedures
Institutional Review Boards (IRBs) play a crucial role in safeguarding the rights and welfare of human research subjects. To enhance...
Sharan Murugan
Feb 52 min read
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USFDA Guidance: Considerations for Complying with 21 CFR 211.110
The US Food and Drug Administration (FDA) has released the Draft Guidance document titled " Considerations for Complying with 21 CFR...
Sharan Murugan
Jan 62 min read
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USFDA's recent Guidance on Biologics: Ophthalmic Products & Development of (CAR) T Cell Products
1. Certain Ophthalmic Products: Policy Regarding Compliance With 21 CFR This guidance is intended to provide information to applicants...
Sharan Murugan
Mar 24, 20221 min read
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