Processes and Practices Applicable to Bioresearch Monitoring Inspections
Processes and Practices Applicable to Bioresearch Monitoring Inspections; Draft Guidance for Industry
Source: fda.gov
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Top Highlights of Washington's Draft Industrial Stormwater Permit for Public Review | Schwabe, Williamson & Wyatt PC
On May 15, the Washington State Department of Ecology (Ecology) released the draft Industrial Stormwater General Permit (Draft ISGP), fact sheet, and application for public comment. The...
Source: jdsupra.com
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.
Source: fda.gov
CVM GFI #290 (VICH GL61) – Pharmaceutical Development
This guidance provides recommendations for the Pharmaceutical Development section for veterinary medicinal products, which provides an opportunity to present the knowledge gained to the development of a product and its manufacturing process.
Source: fda.gov
CVM GFI #187B Heritable Intentional Genomic Alterations in Animals: The Approval Process
This document explains how FDA’s approval process applies to heritable intentional genomic alterations in animals.
Source: fda.gov