US FDA’s Fast Track Designation Policy Faces Unusual Legal Challenge
Vanda Pharmaceuticals contends the agency unfairly denied its request for fast track designation for tradipitant. This appears to be the first time the FDA has been sued over a denial. In FY 2021, CDER denied 78 requests for the designation and granted 173.
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OTC Naloxone NDA In US Gets Fast Track Status
Nonprofit HRT reached a commercial supply agreement for a firm to produce its RiVive naloxone nasal spray still in development after FDA granted fast frack designation for its OTC switch NDA.
Vanda Sues US FDA For Documents Backing Complete Response For Hetlioz Jet Lag Indication
FOIA exemption does not apply to medical and statistical reviews of its sNDA, company claims. It says it needs the information to adapt its development program and determine if the agency made an error.
Vanda Puts Dog Studies In Spotlight In Suit Challenging FDA Clinical Hold
Vanda seeks court order requiring US FDA to lift partial clinical hold on its gastroparesis treatment tradipitant; calls on drug makers to oppose agency's animal research policy, saying it requires unjustified killing of dogs.