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.’
Sponsors running clinical trials in the UK can get a decision on their applications to make substantial but low-risk amendments to their studies within 14 days under a pilot that is testing a streamlined pathway ahead of new clinical trial regulations coming into force in April 2026.
The UK drug regulator has introduced several changes in recent months, such as the introduction of a decentralized manufacturing regulation. Matthew Durdy, CEO of the Cell and Gene Therapy Catapult, explains what these changes mean for the cell and gene industry.
The European Medicines Agency’s inaugural bilateral meeting with the Association of Clinical Research Organizations underscores ACRO’s commitment to advancing innovation and its presence in the EU clinical trials ecosystem.
