"The 2000 FDA Science Forum - FDA and the Science of Safety: New Perspectives" will explore scientific and practical issues related to safety evaluation and risk management of FDA-regulated products. The program, scheduled for Feb. 14-15 at the Washington Convention Center in D.C., will bring FDA scientists together with industry, academia, government agencies, consumer groups and the public. Topics slated for discussion include post-market surveillance and the Food Safety Initiative. The meeting is co-sponsored by FDA's Office of Science, the American Association of Pharmaceutical Scientists, FDA's Office of Women's Health and the agency's chapter of Sigma Xi, a scientific research society
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Advanz Pharma would have had to show that the European Commission’s decision to revoke Ocaliva’s conditional marketing approval risked causing serious and irreparable harm, according to lawyers from Van Bael & Bellis.
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A new pilot aims to take Brazil closer to ‘digital transformation.’
The US MFN executive order is the latest in a series of concerning US developments that are contributing to uncertainty for the European pharmaceutical industry, according to France Biotech’s vice president, Alexandre Regniault.
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.
