FDA, Industry Consider Disclosing Data From Pending, Withdrawn NDAs

The FDA may begin disclosing safety and efficacy data in pending and withdrawn NDAs after a report with recommendations on such disclosures is released early next year by its Transparency Task Force.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