Complex Generic Sponsors Not Using US FDA-EMA Parallel Scientific Advice Program
After nearly two years, the program has received only two requests, driving FDA officials to try to boost interest.
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The first products to be selected for review under the European Medicines Agency’s newly extended OPEN framework for collaboratively assessing marketing applications with non-EU authorities are from Pfizer/AbbVie and Moderna.
The goal is for EMA officials to better understand the process, but becoming an official member still may prove difficult because of the EMA regulatory scheme.
The International Council for Harmonisation has unveiled plans to develop and publish several new guidance documents, including one on bioequivalence for modified-release products, which has been welcomed by global off-patent industry body the IGBA.