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Processes and Practices Applicable to Bioresearch Monitoring Inspections

Processes and Practices Applicable to Bioresearch Monitoring Inspections; Draft Guidance for Industry

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Platform Technology Designation Program for Drug Development

This guidance provides details about the implementation of the platform technology designation program established by section 506K of the Federal Food, Drug, and Cosmetic Act (FD&C Act).

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CVM GFI #115 (VICH GL22) Studies to Evaluate the Safety of Residues of Veterinary Drugs in Human Food: Reproduction Toxicity Testing (Revision 1)

This document provides guidance on reproduction safety studies for veterinary drug residues in human food.

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Remanufacturing of Medical Devices

Remanufacturing of Medical Devices
fda.gov - get the latest breaking news, showbiz & celebrity photos, sport news & rumours, viral videos and top stories from fda.gov Daily Mail and Mail on Sunday newspapers.

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REMS Logic Model: A Framework to Link Program Design With Assessment

REMS Logic Model: A Framework to Link Program Design With Assessment

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