By Michael McCaughan
If you want to market a new pharmaceutical or vaccine ingredient in the US, you should consult a copy of the 2007 Food & Drug Administration Amendments Act.
FDAAA Impact Analysis: Year One
The RPM Report’s analysis of the fi rst year under FDA’s new law makes one fact clear: sponsors seeking approval for never-before-marketed ingredients need to assume the new tools will apply to them.
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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.’
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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.
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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.
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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.