At US Generic Association Annual Meeting, Worries About Sustainability
Executive Summary
ANDA sponsors fret price erosion – and potential changes to 180-day exclusivity.
You may also be interested in...
For Novartis' Generic Advair, Another 18 Months Was Too Far Into The Unknown
Company did not kill its development program because of US FDA feedback, but the experience seems to be another lesson in the difficulty in gaining approval for complex generics.
Azar: International Regulatory Harmonization Will Create More Stable Generic Markets
HHS secretary tells AAM that "fundamental" changes require legislation, but "FDA and our peers are exploring new potential areas for alignment."
Azar: International Regulatory Harmonization Will Create More Stable Generic Markets
HHS secretary tells AAM that "fundamental" changes require legislation, but "FDA and our peers are exploring new potential areas for alignment."
Need a specific report? 1000+ reports available
Buy Reports
Register for our free email digests: