Article Summary:
This week, the FDA made several major announcements and updates across its food, drug, and medical device regulatory activities. On the food side, the agency said it is revoking dozens of outdated food standards and is working to encourage the use of natural food dyes over synthetic ones. The FDA also noted that the Customs and Border Patrol has rescinded the agency’s review exemption for certain low-value imported FDA-regulated products, meaning all such imports must now undergo FDA review.
In the drug and biologics space, the FDA finalized guidance on formal meetings between the agency and sponsors under the Biosimilar User Fee Amendments. The agency also approved Biocon Biologics’ insulin aspart biosimilar as the first interchangeable biosimilar to Novo Nordisk’s NovoLog. Additionally, the FDA’s Office of Orphan Products Development opened its grants program for clinical trials of products targeting rare diseases.
On the medical device front, the FDA issued early alerts about recalls and issues with certain Alaris infusion pumps from BD/CareFusion and microbore extensions from B. Braun. The agency also added pediatric ventricular assist devices to its medical device shortage list while removing intra-aortic balloon and control system devices.
Finally, the text covers a political development, with the U.S. government rejecting proposed 2024 amendments to the International Health Regulations from the World Health Organization, arguing they would undermine U.S. sovereignty during future pandemics.