ANDA Pre-Submission Meetings A 'Challenge' To Integrate Into Development Timelines

Switzerland’s health care products agency said it had cut the time it takes to review marketing applications for certain drugs submitted via its regulatory reliance procedure because it wants to further enhance the appeal of the pathway.

The fall start of PDUFA and GDUFA negotiations could impact the agreement review process and other parts of the schedule intended to ensure it reaches Congress on time.

In its latest attempt to curtail generic versions of Hetlioz, Vanda Pharmaceuticals asked FDA Commissioner Martin Makary to reverse a previous agency decision upholding two ANDA approvals, claiming an “unacceptable culture of bias toward approving generic drugs” at the agency.

Generic drug industry representatives applauded the FDA decision to bring back key staff in the Office of Generic Drugs that were laid off earlier this year.