Antibiotic Development: US FDA Needs Draft Guidance On QIDP Designation, GAO Says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but FDA now interprets provision more broadly to include preventive and diagnostic products, agency says in a new draft guidance clarifying program's requirements and benefits for sponsors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