The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Opioid Dependence: Developing Depot Buprenorphine Products for Treatment.'' This draft guidance addresses drug development and trial design issues relevant to the study of depot buprenorphine products (i.e., modified- release products for injection or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).
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Opioid Dependence: Developing Depot Buprenorphine Products for Treatment; Draft Guidance for Industry; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Opioid Dependence: Developing Depot Buprenorphine Pro...
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83 FR 17666
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“Opioid Dependence: Developing Depot Buprenorphine Products for Treatment; Draft Guidance for Industry; Availability,” thefederalregister.org (April 23, 2018), https://thefederalregister.org/documents/2018-08361/opioid-dependence-developing-depot-buprenorphine-products-for-treatment-draft-guidance-for-industry-availability.