Do Drugs Given Expedited Approval Have More Safety Risks? GAO Says FDA Can't Tell
This article was originally published in The Pink Sheet Daily
Findings could give pharmacovigilance prominence alongside 'breakthrough' and other speed mechanisms in legislative debate on agency reform.
You may also be interested in...
For drug sponsors, FDA's revised process could mean more public disclosures about potential safety risks and more regulatory actions to address those risks. CDER seeks to better leverage scientific and regulatory expertise, including in product quality and compliance, in investigating safety signals under the new policy manual, which also includes target timelines for action.
Sponsors are increasingly using the accelerated approval pathway, but research continues to be critical about its aspects.
Changes in legacy DARRTS system, transition to new platform and standardized format for annual report submission should improve FDA's tracking of postmarketing requirements, agency tells Office of the Inspector General.