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Precedent-setting Lawsuit: Free Speech vs. Off-Label Drug Promotion
Allergan is suing the FDA regarding the right to distribute safety information on the off-label use of its drugs.
Enforced 15-day limit on FDA form 483 responses
Starting 15 September 2009, the FDA began enforcing a 15-day limit on post-inspection responses to an FDA-issued form 483 (Inspectional Observations).
FDA Issues Draft Guidance on Risk Evaluation and Mitigation Strategies
The FDA announced (30 Sept 2009) the availability of the first draft guidance for industry on Risk Evaluation and Mitigation Strategies (REMS).
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