Transcription of FDA Best Practices Manual Update - AAEI
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FDA Best Practices Manual Update - AAEI
FDA IMPORT REQUIREMENTS. AND BEST Practices FOR. DRUGS AND MEDICAL DEVICES. September 2015. FDA Import Requirements and Best Practices for Drugs and Medical Devices FDA Import Requirements and Best Practices for Drugs and Medical Devices Table of Contents 1. Introduction and Abbreviation Table .. 3. 2. Importation Process Diagram .. 6. 3. PREDICT .. 6. 4. MARCS. a. Data Transmission Requirements .. 8. b. FDA Establishment Registration .. 12. 5. 12. 6. Import Trade Auxiliary Communications System (ITACS) .. 13. 7. Drugs a. What is a drug? .. 14. b. What is an unapproved drug? .. 14. c. Drug Development & Steps Toward Drug Approval .. 14. d. API 15. e. Drug Listing.
This manual should be utilized as one of many tools in an importer’s tool box for compliance with U.S. Participating Government Agencies with import jurisdiction. This manual serves as a reference source and not meant to provide any legal or regulatory advice. Please note that the abbreviation FD&C Act refers to the Food, Drug & Cosmetic Act. ...
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