The Food and Drug Administration (FDA or Agency) is announcing the availability of a guidance for industry entitled ``Duchenne Muscular Dystrophy and Related Dystrophinopathies: Developing Drugs for Treatment.'' The purpose of this guidance is to assist sponsors in the clinical development of drugs for the treatment of X-linked Duchenne muscular dystrophy (DMD) and related dystrophinopathies. This guidance finalizes the draft guidance of the same name issued on June 10, 2015.
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Duchenne Muscular Dystrophy and Related Dystrophinopathies: Developing Drugs for Treatment; Guidance for Industry; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a guidance for industry entitled ``Duchenne Muscular Dystrophy and Related Dystrophinopathies:...
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83 FR 7050
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“Duchenne Muscular Dystrophy and Related Dystrophinopathies: Developing Drugs for Treatment; Guidance for Industry; Availability,” thefederalregister.org (February 16, 2018), https://thefederalregister.org/documents/2018-03225/duchenne-muscular-dystrophy-and-related-dystrophinopathies-developing-drugs-for-treatment-guidance-for-industry-availabi.