FDA’s final process validation guidance clarifies that legacy products, or products that are currently on the market, will be exempt from early stage process validation. The guidance also endorses the use of process analytical technology for monitoring product quality.
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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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The European Medicines Agency says that Eli Lilly's Alzheimer's disease drug should be approved for use in the EU, now that it has re-examined the negative opinion it previously adopted.
