Breakthrough Nears 50 Approvals: Process Improving, But “Gray Areas” Persist
Reflecting on the last three-plus years, agency officials say the quality of requests for breakthrough are improving, and review divisions outside of the initial base of oncology are becoming more comfortable with granting designations.
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Keeping Track: Lilly's Olaratumab, Cempra's Solithromycin, AAA's Lutathera Complete Submissions; End Of The Road For Rociletinib
The latest drug development news and highlights from our FDA Performance Tracker.
Agency now allows sponsors of potential breakthrough therapies to request preliminary advice, but sponsors may not necessarily want to use it.
FDA completed a major reorganization of the way it regulates manufacturing quality of drugs and biologics with the launch of the Office of Pharmaceutical Quality within the Center for Drugs. OPQ is part of Janet Woodcock’s decade-long effort to ensure a consistent, safe drug supply. The immediate impact on industry will be minimal, but manufacturers that haven’t invested in facility upgrades will face a steep learning curve.