FDA to drugmakers: Give warning of product discontinuations

October 22, 2007

A new FDA final rule requires manufacturers that make life-sustaining single-source drugs to give six-month notice before they discontinue these products.

The FDA has issued a final rule requiring manufacturers that discontinue a single-source life-supporting drug that's not derived from human tissue and replaced by a recombinant product to notify the agency at least six months before they stop producing the item. The agency explained that these new postmarketing reporting requirements will give patients who are taking these drugs an opportunity to find an alternative. The final rule was published in the