FDA finalizes rule to regulate insulin as biological product
The Food and Drug Administration today released a regulating certain protein products, such as insulin, as biological products rather than drugs effective March 23. Authorized by the Biologics Price Competition and Innovation Act of 2009, the change will allow new insulin products, and certain other protein products, to apply for marketing approval through the abbreviated pathway for biosimilar or interchangeable products in an effort to increase market competition and lower prices. For more on the change, see the FDA FAQs for health care and .
In other news, FDA today released a of gene-drug interactions based on FDA labeling and other scientific evidence, which it plans to update periodically to aid prescribers.
Related News Articles
Headline
The Food and Drug Administration Aug. 7 announced a new program to help improve the domestic pharmaceutical supply chain by increasing regulatory…
Headline
The Department of Justice July 29 released guidance for federal funding recipients on unlawful discrimination “on the basis of race, color, national origin,…
Headline
Centers for Medicare & Medicaid Services Administrator Mehmet Oz, M.D., July 19 visited AtlantiCare health system in New Jersey, making stops at its…
Headline
The House has begun consideration of the Senate-passed version of the One Big Beautiful Bill Act (H.R. 1). This continues to be a fluid…
Headline
The Senate Health, Education, Labor, and Pensions Committee today released its text for the budget reconciliation bill. The text includes one health care…
Headline
AHA May 23 submitted recommendations to the Department of Justice and Federal Trade Commission in response to the agencies’ requests for information on…