FDA Says New GRMPs Will Shift Drug Review Workload To Earlier In Cycle
This article was originally published in Pharmaceutical Approvals Monthly
Sponsors and FDA reviewers will have to adjust to the workload of a drug review shifting earlier in the review cycle as the agency implements Good Review Management Principles, now renamed the "21st Century Review Process."
You may also be interested in...
Even as the agency wrestles with the transformation brought by FDAAA, shifts in how it processes NDAs may be the "most important," CDER official says.
As FDA rolls out its Good Review Management Principles - its attempt to improve FDA's timely review of drug applications through professional best practices - the agency is stressing the importance of sponsors submitting complete applications to facilitate this process
ATLANTA - An agency-wide initiative to implement Good Review Management Principles at the Center for Drug Evaluation and Research should lead to more first-cycle reviews, CDER Associate Director of Regulatory Affairs Kim Colangelo said at a June 18 session of the Drug Information Association annual meeting