July 21 (Reuters) – The U.S. FDA said on Tuesday it is launching a pilot program to encourage domestic manufacturing of animal health drugs and reduce the risk of supply chain disruptions.
The health regulator’s Center for Veterinary Medicine said the initiative aims to prevent animal drug shortages.
Here are some details:
• According to U.S. Food and Drug Administration, the new program will prioritize reviews of animal drug applications where both the finished product and the active ingredients are made in the U.S.
• The FDA is also offering consideration of faster review of drug-quality and manufacturing information in such cases.
• Under the pilot, eligible drug developers may include a second domestic active ingredient source in an original application or technical section submission, provided at least one active ingredient source is domestically manufactured.
• FDA said the policy is intended to avoid the need for sponsors to file a post-approval supplemental application.
(Reporting by Christy Santhosh in Bengaluru; Editing by Sahal Muhammed)
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