FDA Details Clinical Trial Criteria For Combo Drugs

Law360, New York (June 14, 2013, 3:14 PM EDT) -- The U.S. Food and Drug Administration on Thursday finalized guidance on when and how drugs intended for combination therapy can be tested together in support of joint approval, saying such efforts should be reserved for serious illnesses and involve studying the drugs separately whenever possible.

Use of two or more medicines together has been a game changer in treatment of several confounding diseases, including cancer, HIV and AIDS, creating the need for guidance on how such drugs can be studied within approval pathways that have traditionally...
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