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Processes and Practices Applicable to Bioresearch Monitoring Inspections

Processes and Practices Applicable to Bioresearch Monitoring Inspections; Draft Guidance for Industry ....

Radiological Health , Office Of Clinical , Drug Administration , Office Of Regulatory Affairs , Guidance Issuing Office , Submit Comments , Clinical Policy , Biologics Evaluation , Drug Evaluation , Food Safety , Practices Applicable , Bioresearch Monitoring Inspections , Drug Omnibus Reform Act ,

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. ....

United States , Washington State Department Of Ecology , Washington State Department , Industrial Stormwater General Permit , Transportation Facilities , Revised Definition , Sampling Point , Submit Comments , Public Comment Period , State Department ,

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. ....

Drug Administration , Guidance Issuing Office , Submit Comments , Acceptable Daily Intakes ,

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. ....

Guidance Issuing Office , Drug Administration , Submit Comments , Pharmaceutical Development ,

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. ....

Guidance Issuing Office , Drug Administration , Submit Comments , Intentional Genomic Alterations , Risk Based Approach , Approval Process ,