Zdrowie i gospodarka · 23/04/2018

Opioid Dependence: Developing Depot Buprenorphine Products for Treatment; Draft Guidance for Industry; Availability

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled "Opioid Dependence: Developing Depot Buprenorphine Products for Treatment." This draft guidance addresses drug development and trial design issues relevant to the study of depot buprenorphine products (i.e., modified- release products for injection or implantation).

Source: Federal Register — Food and Drug AdministrationOpen original release →

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