The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled ``Hypertension: Developing Fixed-Combination Drug Products for Treatment.'' The purpose of this guidance is to assist sponsors in the clinical development of fixed-combination drug products for the treatment of hypertension. The guidance focuses on development of two- drug combinations of previously approved drug products. This guidance incorporates the comments received for and finalizes the draft guidance for industry entitled ``Hypertension: Developing Fixed-Dose Combination Drugs for Treatment'' issued on January 26, 2018.
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Hypertension: Developing Fixed-Combination Drug Products for Treatment; Guidance for Industry; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled ``Hypertension: Developing Fixed-Combination Drug Produ...
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83 FR 55728
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“Hypertension: Developing Fixed-Combination Drug Products for Treatment; Guidance for Industry; Availability,” thefederalregister.org (November 7, 2018), https://thefederalregister.org/documents/2018-24315/hypertension-developing-fixed-combination-drug-products-for-treatment-guidance-for-industry-availability.