Otsuka America Inc.
www.otsuka-america.com
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Latest From Otsuka America Inc.
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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