Complex Generics: US FDA Still Wants Comparative Clinical Endpoint Studies For Inhaled, Nasal Drugs
Despite in-vitro advances, FDA officials say more work is needed in refining alternative models before agency disbands its weight-of-evidence approach.
You may also be interested in...
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.
Commissioner Gottlieb previews actions agency intends to take in 2019 to smooth the regulatory and scientific pathway for generics of complex drugs, including draft guidance with recommendations on establishing active ingredient sameness.
Association For Accessible Medicines representatives say animal studies and in-silico trials could reduce the need for BE studies, but OGD director is not sure.