ComplianceOnline

White Paper: The FDA’s New Animal Drug Application Process: 5 Best Practices for Ensuring Compliance

  • By: ComplianceOnline
  • Date: July 08, 2014
Abstract:

The FDA has strengthened its scrutiny of animal drug products as public awareness of the issues surrounding their use and adverse events have increased. A number of manufacturers have been warned about marketing products with treatment claims without first obtaining approval from the agency. The approval process for a veterinary drug is as complicated and rigorously analyzed by the FDA as the one for human medicines. This White Paper details what is considered an animal drug, the different types of applications and finally explains five best practices that manufacturers can adopt in order to ensure better compliance with the application process for a new animal drug.

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