Antibiotic Development: US FDA Needs Draft Guidance On QIDP Designation, GAO Says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.
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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.
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but FDA now interprets provision more broadly to include preventive and diagnostic products, agency says in a new draft guidance clarifying program's requirements and benefits for sponsors
Antibiotics Pipeline Is Lively, But Sponsors Are Fragile
Regulatory uncertainty could imperil the crop of emerging companies making a go of it in the incentive-laden US anti-infective space.