21 nov 2017 - FDA issued a final guidance titled “General Principles for Evaluating the Abuse Deterrence of Generic Solid Oral Opioid Drug Products.” This guidance recommends studies, including comparative in vitro and pharmacokinetic studies, that the potential abbreviated new drug application (ANDA) applicant should conduct and submit to FDA in an ANDA to demonstrate that a generic solid oral opioid drug product is no less abuse-deterrent than its reference listed drug with respect to all potential routes of
Ajouté au bande de temps:
Date:
21 nov 2017
Maintenaint
~ Il y a 7 ans et 11 mois