By Michael McCaughan
The meeting was entitled "Post-Market Drug Safety – The World After FDAAA," but the Institute of Medicine could easily have called its Sept. 2 update "What Have We Done?"
It has been three years since an Institute of Medicine report on FDA's drug safety system, and two years since the landmark FDA Amendments Act that followed. As those anniversaries approached, IoM convened a workshop for an update on the changes at FDA since FDAAA. Here's what we heard.
By Michael McCaughan
The meeting was entitled "Post-Market Drug Safety – The World After FDAAA," but the Institute of Medicine could easily have called its Sept. 2 update "What Have We Done?"
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.