PDUFA Update: FDA Wants To Automatically Extend Complex Application Reviews
Executive Summary
FDA wants industry to agree to a set of reasons that would automatically trigger a longer application review as part of the negotiations on reauthorizing the Prescription Drug User Fee Act.
You may also be interested in...
NDA Data Standardization Efforts Emerging Along Public, Private Fronts
FDA appears to be using a multi-front strategy for designing and implementing plans to standardize electronic data formats and application filings.
NDA Data Standardization Efforts Emerging Along Public, Private Fronts
FDA appears to be using a multi-front strategy for designing and implementing plans to standardize electronic data formats and application filings.
PDUFA V: FDA Could Offer Non-Binding Advice, If It’s Binding
FDA is interested in giving non-binding advice to drug sponsors under PDUFA V, as long as it is binding, officials told industry.