Home » FDA, Industry Consider Disclosing Data From Pending, Withdrawn NDAs
FDA, Industry Consider Disclosing Data From Pending, Withdrawn NDAs
The FDA may begin disclosing safety
and efficacy data in pending and withdrawn NDAs after a report with recommendations on such disclosures is released early next year by its Transparency
Task Force. The report would be posted for public comment before any action were taken, Joshua Sharfstein, FDA principal deputy commissioner and leader
of the task force, said at a meeting last week.
Washington Drug Letter
Washington Drug Letter
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