US Antibiotic Incentives Extended To Drugs That Prevent Or Diagnose Infections
Law defines QIDP as antibacterials and antifungals intended to 'treat' serious infections, but FDA now interprets provision more broadly to include preventive and diagnostic products, agency says in a new draft guidance clarifying program's requirements and benefits for sponsors
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US FDA Joins Chorus Of Concerns About Results Of GAIN Act
It's too early to say whether program is working, FDA tell Congress; agency has awarded 147 QIDP designations, but none of 12 approved antibacterals have new mechanism of action.
Antibiotic Development: US FDA Needs Draft Guidance On QIDP Designation, GAO Says
Sponsors lack comprehensive advice on how to access benefits of GAIN legislation's incentives, which include the opportunity for fast track designation, priority review designation and five years of market exclusivity, government watchdog says.
FDA Expedited Pathways Guidance Expands Range Of Eligible Products
Drugs intended to prevent a serious condition or reduce likelihood of disease progression may qualify, as may products intended to diminish serious adverse events associated with current treatment.