Complete response: FDA plans to finalize its proposed rule to replace "approvable"/"not approvable" letters in response to NDAs with complete response letters in October, according to HHS' spring "unified agenda." The rule is intended to fulfill the 1997 FDA Modernization Act requirement to discontinue "approvable"/"not approvable" letters in favor of a standard format. While complete response letters will still identify deficiencies in an application, they are believed less likely to create overreaction by investors. The proposed rule was issued in July 2004 (1"The Pink Sheet" July 26, 2004, p. 10)...
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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 European Medicines Agency has revised the sponsor handbook for the Clinical Trials Information System, bringing together guidance that was previously scattered across multiple platforms and documents to help sponsors navigate the trial process more efficiently.
The long-time industry executive led several drug approvals but may have a lot to learn about the intimate details of application review and the Center for Drug Evaluation and Research.
The US FDA's Psychopharmacology Advisory Committee emphasized high standards over regulatory flexibility while turning down Otsuka's brexpiprazole plus serotonin for post-traumatic stress disorder based on conflicting Phase III trials and post-hoc Phase II analyses.
