Regional bridging studies may be unnecessary for "ethnically insensitive" drugs -- ICH guidance.
Executive Summary
ETHNIC BRIDGING DATA MAY BE UNNECESSARY, ICH GUIDANCE suggests, when a drug's activity is not sensitive to ethnicity or a geographic region's experience with pharmacologically related compounds makes extrapolation of clinical data feasible. The International Conference on Harmonization draft guidance on "Ethnic Factors in the Acceptability of Foreign Clinical Data," published in the July 31 Federal Register, outlines "regulatory and development strategies that will permit adequate evaluation of the influence of ethnic factors while minimizing duplication of clinical studies and expediting the drug approval process," FDA wrote. FDA will accept comments on the document through Oct. 29.
You may also be interested in...
Part D Discount Liability Coming Into Focus: CMS Releases Drug Cost Data
Newly released Medicare Part D data sheds light on the sales hit that branded pharmaceutical manufacturers will face when the coverage gap discount program gets under way in 2011
FDA Skin Infections Guidance Spurs Debate On Endpoint Relevance
FDA appears headed for a showdown with clinicians and the pharmaceutical industry over the proposed new clinical trial endpoints for acute bacterial skin and skin structure infections, the guidance's approach for justifying a non-inferiority margin and proposed changes in the types of patients that should be enrolled in trials
Shire Hopes To Sow Future Deals With $50M Venture Fund
Specialty drug maker Shire has quietly begun scouting deals with a brand-new $50 million venture fund, the latest of several in-house investment arms to launch with their parent company's pipelines, not profits, as the measure of their worth