FDA “Safety First” Implementation: Drug Review, Drug Safety Offices To Meet Regularly
This article was originally published in The Pink Sheet Daily
Executive Summary
Topics of discussion for joint meetings will range from broad regulatory questions to specific issues about an NDA or BLA.
You may also be interested in...
REMS Reform Looks To Be Theme Of PDUFA V: Stakeholders Call For Standardization, Earlier Notice
The biggest changes that came out of the FDA Amendments Act, the last round of Prescription Drug User Fee Act reauthorization, were FDA's augmented drug safety authorities, most specifically the Risk Evaluation and Mitigation Strategy tool. Going into the next round of PDUFA negotiations, a major focus will be on improving the implementation of the REMS program
REMS Reform Looks To Be Theme Of PDUFA V: Stakeholders Call For Standardization, Earlier Notice
The biggest changes that came out of the FDA Amendments Act, the last round of Prescription Drug User Fee Act reauthorization, were FDA's augmented drug safety authorities, most specifically the Risk Evaluation and Mitigation Strategy tool. Going into the next round of PDUFA negotiations, a major focus will be on improving the implementation of the REMS program
FDA Drug Review, Surveillance Offices Agree To Share Regulatory Authority Over Safety
Memorandum of understanding gives Office of Surveillance and Epidemiology a greater voice on regulatory issues related to drug safety.