Toxicological Insights for the Global Pharmaceutical Industry
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GI models aid preclinical drug development
Seventh Wave Laboratories now offers a battery of gastrointestinal (GI) preclinical models to help clients to assess the behaviour of oral medications.
FDA Transparency Initiative
The FDA launched a web-based resource called “FDA Basics” that provides basic information about the Agency and how it does its work.
Evolving FDA and EMEA Collaborations
Distillation of an interview with Murray Lumpkin, who is spearheading the FDA’s efforts to collaborate with the EMEA, discussed the history and context of the collaboration and drug safety (preclinical and clinical) initiatives, among others.
Drug Safety Emphasis Did Not Slow FDA Drug Approvals in 2009
New drugs cleared by the FDA in 2009 kept pace with 2008 and boxed warnings decreased, suggesting the tougher approach to drug safety has not slowed approvals.
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.
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