Risk Evaluation and Mitigation Strategy (REMS) for Certain Drugs and Biologics

The U.S. Food and Drug Administration has identified 25 drugs and biologic products that will be required to submit safety plans called Risk Evaluation and Mitigation Strategy (REMS), the FDA said in a Federal Register notice published today.

Under the Food and Drug Administration Amendments Act of 2007 (FDAAA), FDA can require manufacturers to submit a REMS when a drug first comes on the market, or later if FDA becomes aware of new safety data about the drug. The manufacturers of the 25 drugs and biologic products identified in today’s notice must submit to the agency a proposed REMS by Sept. 21, 2008.

Effect

The user fees that will help support implementation of the Risk Minimization Action Plans … and the penalties, starting at $250,000 and potentially reaching $10 million, that can now be imposed for failure to adhere to drug safety provisions … are why it’s crucial for you to attend the Risk Management and Drug Safety Summit.

Source: FDA

2 Responses to Risk Evaluation and Mitigation Strategy (REMS) for Certain Drugs and Biologics

  1. Even one can say not bad. It is obvious that the author has tried hard in the article to show us the main thing. Written with determination and patience.

  2. The style of writing is very familiar to me. Have you written guest posts for other blogs?

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