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Processes and Practices Applicable to Bioresearch Monitoring Inspections

June 4, 2024

Processes and Practices Applicable to Bioresearch Monitoring Inspections; Draft Guidance for Industry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

Source: fda.gov

Top Highlights of Washington's Draft Industrial Stormwater Permit for Public Review | Schwabe, Williamson & Wyatt PC

May 22, 2024

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

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)

May 22, 2024

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

Source: fda.gov

CVM GFI #290 (VICH GL61) – Pharmaceutical Development

May 3, 2024

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

Source: fda.gov

CVM GFI #187B Heritable Intentional Genomic Alterations in Animals: The Approval Process

May 1, 2024

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

Source: fda.gov

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Enforcement Policy for Certain In Vitro Diagnostic Devices for Immediate Public Health Response in the Absence of a Declaration under Section 564

April 29, 2024

This draft guidance describes an enforcement policy for certain IVDs for immediate public health response in the absence of a declaration under section 564.

United States Guidance Issuing Office Drug Administration Radiological Health Submit Comments Federal Food

Source: fda.gov