FDA issues draft guidance to industry
Posted on: Thursday, 1 October 2009, 08:05 CDT
The U.S. Food and Drug Administration says it has issued the first draft guidance for industry on risk evaluation and mitigation strategies.
The plan describes information the pharmaceutical industry must submit for certain drugs or biologics. Officials said Congress granted the federal agency the authority to require the submission and implementation of such plans if the FDA determines it is necessary to ensure a drug's benefits outweigh its risks.
The FDA said components include medication guides; patient package inserts; a communication plan for healthcare providers; elements to ensure safe use including requirements for those who prescribe, dispense, or use the drug; and a timetable for submission.
With this new guidance, manufacturers will have a useful blueprint for how to develop these important safety strategies,
said Dr. Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research.
Source: United Press International
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