Toxicological Insights for the Global Pharmaceutical Industry
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Drug Safety: Current overview of FDA postmarket surveillance
The formation of a detailed, continually updated, publicly available clinical database has been proposed for postmarket drug surveillance.
Drug Safety: FDA’s Postmarket Decision-making Process
Historical view on FDA’s progress on a variety of initiatives to improve its postmarket drug surveillance.
Orphan Diseases… a new pharmaceutical strategy?
The orphan disease niche (i.e., low volume: high cost) has become an increasingly attractive lure to major pharmaceutical companies.
Personalized Medicine – why the sudden popularity?
Is personalized medicine a new or an old idea? What has changed to increase the popularity of this option? Are these assumptions valid?
Computational techniques suggest new ways to find drugs’ unintended targets
Chemoinformatics, statistical programs, and experimental techniques are being utilized to predict off-target interactions and to minimize drug adverse effects.
Was the REMS meant to regulate prescribers and pharmacists?
This article, which gives a good overview of the status and use of Risk Evaluation and Mitigation Strategy (REMS) by the FDA and the pharmaceutical industry, questions whether Congress and the FDA have exceeded their authority by indirectly regulating professions downstream of drug/biological manufacturing.
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FDA Issues Draft Guidance on Risk Evaluation and Mitigation Strategies
The FDA announced (30 Sept 2009) the availability of the first draft guidance for industry on Risk Evaluation and Mitigation Strategies (REMS).
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