Toxicological Insights for the Global Pharmaceutical Industry
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Will proposed health care reform bill provisions enhance perceived drug safety?
Four proposals that address drug advertising and marketing issues may be incorporated into the final health care reform bill: 1) tax deduction for drug advertising, 2) disclosure of industry payments to physicians, 3) to stop use of patient- and prescriber-identifiable information by sales reps, and 4) to alter drug labels and advertising to better define benefit/risk and inclusion of comparative effectiveness information.
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FDA Issues Draft Guidance on Risk Evaluation and Mitigation Strategies
The FDA announced (30 Sept 2009) the availability of the first draft guidance for industry on Risk Evaluation and Mitigation Strategies (REMS).
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