Vanda Pharmaceuticals, Inc. is once again pursuing novel litigation against the US Food and Drug Administration, this time claiming the agency shared confidential information in its new drug applications with generic competitors.
Vanda’s Fourth Suit Against US FDA Claims Agency Shared Its Manufacturing Trade Secrets
Vanda is fighting FDA’s rejection of jet lag indication for Hetlioz as it faces generic competition for sleep-wake disorder treatment. Federal Circuit finds four Hetlioz patents invalid.
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FDA staffing cuts are making negotiation preparations more difficult, but also could mean the result is a smaller user fee renewal package.
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Stakeholders are pleading for newly confirmed FDA Commissioner Martin Makary to stand up for the agency's high scientific standards and staff as he begins his term.