Data Standards: Technical ‘Postmortem’ Could Clarify US FDA Preferences, Industry Says
Feedback on application-specific data submission issues that vexed the agency but were not onerous enough to warrant a refuse-to-file letter would help inform future filings and reduce variation across sponsors, industry representatives say at meeting on analytical data standards.
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Ellis Unger tells the Pink Sheet that Premarket Safety Assessment Working Group is overseeing various projects aimed at bringing more standardization to NDA and BLA safety assessments across applications and review divisions, while also bolstering the quality of those reviews; initiatives include development of queries that group similar types of adverse events together and standardizing the safety information requested at pre-NDA meetings.
Former US FDA Commissioner Robert Califf remains eager to encourage broader use of real-world evidence – but his blunt, pessimistic read on the state of biopharma innovation is remarkable coming from a former FDA head.
Binding final guidance says refuse-to-file or refuse-to-receive actions will be taken if NDAs, BLAs or ANDAs contain study data that don’t conform to new standards that take effect starting in December 2016.