US FDA Releases Slew Of Guidances On A Fell Day For Complex Generics
New and updated guidances are good news for ANDA sponsors, but timing – coming the day Sandoz announced a CRL for its Advair copy – underscores challenges that developers of complex generics face.
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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.
Gottlieb On Pursuing Legislative Reform: Start Small, Build Later
Former US FDA commissioner Scott Gottlieb encouraged stakeholders at the Association for Accessible Medicine's GRxBiosims 2019 meeting to start small in scope when pushing for legislative changes, which makes it easier to build on later.
Keeping Track: FDA Approves First Generic Advair, But Alkermes And Sunovion Land CRLs
The latest drug development news and highlights from our US FDA Performance Tracker.