Maligned FDA Deserves Standing Ovation
Oftentimes, we forget how valuable our FDA is because we are used to only seeing the sensational critiques in the media: unwarranted drug approvals, inadequate surveillance, negligent public alerts or inappropriate industry influence.
Yet, there are moments to celebrate the FDA, as well. Under great pressure, last week, the FDA’s Center for Drug Evaluation and Research (CDER) and Center for Biologic Evaluation and Research (CBER) released a much awaited and much needed draft guidance for industry, entitled, “Nonproprietary Naming of Biological Products and also a Proposed Rule: Designation of Official Names and Proper Names for Certain Biological Products.” The draft guidance details how “certain biological products,” more commonly known as biosimilars, will be given distinctive names from their reference product, essentially signposting their recognition that unique names protect patient safety.
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