October 2, 2018
Authored and Edited by Benjamin T. Hemmelgarn; M. Andrew Holtman, Ph.D.
On September 24, 2018, FDA issued draft guidance on good review management principles and practices (GRMPs) for NDAs and BLAs that remains open for a 90-day comment period. The GRMPs are guidelines for the drug review process that exist to provide prompt patient access to life-saving therapies. The draft guidance describes the fundamental values and operational principles that comprise the GMRPs as well as defines the relationship between applicants and review staff during the review process.
The draft guidance identifies these three fundamental values to ensure the highest quality applications and review processes:
Operational principles are the five elements of a thorough yet efficient review process:
These fundamental values and operational procedures make up the GMRPs that applicants and review staff should follow to provide patients timely access to new drugs and biological products.
Readers are encouraged to read the draft guidance, also available on FDA's website.
Food and Drug Administration (FDA), FDA Guidance, Biologic License Application (BLA), new drug application (NDA)
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