Risk-Based Quality Assessment Growing Among ANDA Chemistry Reviews
The Office of Generic Drugs implemented risk-based quality assessment for some ANDA chemistry reviews in 2013 and found it helped speed up the process and enabled reviewers to better handle the submission volume.
You may also be interested in...
Experts say one idea may be to borrow some new drug staff to help relieve the pressure; FDA says it will use all available resources.
Horizon CEO says safety trial will be conducted in a larger patient population following discussions during the US FDA advisory committee meeting.