federal_register: 2019-26264

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2019-26264 Interstitial Cystitis/Bladder Pain Syndrome: Establishing Effectiveness of Drugs for Treatment; Draft Guidance for Industry; Availability Notice The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled "Interstitial Cystitis/Bladder Pain Syndrome (IC/BPS): Establishing Effectiveness of Drugs for Treatment." There is pharmaceutical and stakeholder interest in the development of new drugs for patients with IC/BPS. This draft guidance provides FDA's recommendations for clinical trials intended to establish clinical effectiveness and safety for drugs intended to treat IC/BPS. 2019-12-05 2019 12 https://www.federalregister.gov/documents/2019/12/05/2019-26264/interstitial-cystitisbladder-pain-syndrome-establishing-effectiveness-of-drugs-for-treatment-draft https://www.govinfo.gov/content/pkg/FR-2019-12-05/pdf/2019-26264.pdf Health and Human Services Department; Food and Drug Administration 221,199 The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled "Interstitial Cystitis/Bladder Pain Syndrome (IC/BPS): Establishing Effectiveness of Drugs for Treatment." There is pharmaceutical...

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