federal_register: 2021-26923

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document_number title type abstract publication_date pub_year pub_month html_url pdf_url agency_names agency_ids excerpts
2021-26923 Bowel Cleansing for Colonoscopy: Efficacy and Safety Considerations for Developing New Products; Draft Guidance for Industry; Availability Notice The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Bowel Cleansing for Colonoscopy: Efficacy and Safety Considerations for Developing New Products.'' The purpose of this draft guidance is to provide FDA's current thinking regarding the necessary attributes of patients for enrollment in clinical trials, efficacy assessments, and safety assessments. The draft guidance is intended to serve as a focus for continued discussion among FDA's Division of Gastroenterology, pharmaceutical sponsors, the academic community, and the public. 2021-12-13 2021 12 https://www.federalregister.gov/documents/2021/12/13/2021-26923/bowel-cleansing-for-colonoscopy-efficacy-and-safety-considerations-for-developing-new-products-draft https://www.govinfo.gov/content/pkg/FR-2021-12-13/pdf/2021-26923.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and Drug Administration 221,199 The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Bowel Cleansing for Colonoscopy: Efficacy and Safety Considerations for Developing New Products.'' The purpose of this draft...

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