FDA Unveils Plan To Boost Transparency To Industry
This article was originally published in The Tan Sheet
Executive Summary
FDA identified 19 steps to improve its communications with drug and medical device manufacturers, promising quicker responses to industry questions.
You may also be interested in...
Compliance Data Should Be Linked To Enforcement Results – FDA Task Force
FDA’s transparency task force proposes a multi-pronged approach to make the agency’s compliance and enforcement data more accessible and user-friendly online.
FDA Congressional Relations, Internal Structure May Change With Sharfstein Exit
The departure of Principal Deputy Commissioner Josh Sharfstein provides FDA an opportunity to take stock of its relationship with Congress and to re-evaluate its organizational structure.
Disclosure Of NDA Filings Recommended In Transparency Report
Firms may have to marshal legal arguments to prevent public disclosure of drug development milestones, including OTC switch filings, following the FDA Transparency Task Force's recommendation that the agency disclose when applications are submitted and withdrawn