Processes and Practices Applicable to Bioresearch Monitoring Inspections: Draft Guidance for Industry
Information
Type
Guidance
Regulated products
Animal & Veterinary, Biologics, Dietary Supplements, Drugs, Food & Beverages, Medical Devices, Radiation-Emitting Products, Tobacco
Topics
Administrative / Procedural, Biopharmaceutics, Biosimilars, Compliance, Generic Drugs, Inspection, International, Investigational Device Exemption (IDE), Postmarket, Premarket
Published
June 5, 2024
Last updated
June 4, 2024
Description
A draft guidance document for the biopharmaceutical industry covering processes and practices for bioresearch monitoring inspections, including topics like compliance, inspections, and various drug categories.
Tags
Organization
Country / Region
United States
License
Other (Public Domain)