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Entreprise · 17/05/20021 min de lecture
Draft Guidance for Industry on Topical Dermatological Drug Product NDAs and ANDAs-In Vivo Bioavailability, Bioequivalence, In Vitro Release and Associated Studies; Withdrawal
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Résumé
The Food and Drug Administration (FDA) is announcing the withdrawal of a draft guidance for industry entitled "Topical Dermatological Drug Product NDAs and ANDAs--In Vivo Bioavailability, Bioequivalence, In Vitro Release, and Associated Studies." After careful consideration of the comments from the public and public advisory committees, FDA has decided to withdraw the draft guidance.
Langue originale de la source: Federal Register — Food and Drug AdministrationOuvrir le communiqué original →