Roche should use pharmacogenomic techniques to explore the potential link between Accutane and depression, FDA Dermatologic & Ophthalmic Drugs Advisory Committee consultant Robert Branch, MD, University of Pittsburgh Medical Center, suggested.
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Australia is reviewing its human tissue laws for the first time in almost 50 years, and is hoping to reduce barriers to access for scientific researchers, for instance by addressing issues with access to cell lines for developing drugs.
At this year’s DIA China meeting, the national regulator updated its policy focus areas for this year, including clinical trial data protection and pilot projects to shorten IND approval times.
CBER's Nicole Verdun wants rare disease sponsors with stalled treatments to circle back because the FDA's evolved thinking on clinical trial designs may offer another opportunity for cast away products.
