FDA Wants Industry Input on New Drug Review Process
| Posted: 9 July 2012
By Alexander Gaffney
The US Food and Drug Administration (FDA) has released a call for comments on a new transparency and drug review program contained within the Prescription Drug User Fee Act V (PDUFA V), which is expected to be signed into law by President Barack Obama in July 2012.
Specifically, FDA’s Program for Enhanced Review Transparency and Communication for New Molecular Entity (NME) New Drug Applications (NDAs) and Original Biologics License Applications (BLAs) would “enhance review transparency and communication between FDA and applicants on these complex applications,” FDA said in a Federal Register posting.
FDA explained the existing goals of 6- and 10-month reviews for priority and standard drug applications have become “increasingly challenging to meet, particularly for more complex applications like NME NDAs and original BLAs.”
To help “increase efficiency in the review process,” FDA said it supported a new review model in PDUFA V to implement additional communications and meetings throughout the review cycle. “An efficient and effective review process that allows for timely responses to FDA questions can help ensure timely patient access to safe, effective, and high quality new drugs and biologics,” FDA wrote.
“To accommodate this increased interaction during regulatory review and to address the need for additional time to review these complex applications, FDA's review clock will begin after the 60-day administrative filing review period for applications reviewed under the Program,” FDA explained. The modified review clock will be effective 1 October and last until the Food and Drug Administration Safety and Innovation Act’s 30 September 2017 expiration.
The agency said it looking to assess the potential impact of the changing review process on applicants and is seeking comments from industry in order to address any problems in advance of the 1 October 2012 commencement date of the program. Those interested in commenting on the proposed implantation of the program have until 6 August 2012 to submit comments to FDA.
FDA - Assessment of the Program for Enhanced Review Transparency and Communication for New Molecular Entity New Drug Applications and Original Biologics License Applications in Prescription Drug User Fee Act V; Request for Comments