federal_register: 2023-20592

All Federal Register documents (rules, proposed rules, notices, presidential documents) from 1994 to present. Nearly 1M documents with full-text search.

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document_number title type abstract publication_date pub_year pub_month html_url pdf_url agency_names agency_ids excerpts regulation_id_numbers
2023-20592 Formal Meetings Between the Food and Drug Administration and Sponsors or Applicants of Prescription Drug User Fee Act Products; Draft Guidance for Industry; Availability Notice The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled "Formal Meetings Between the FDA and Sponsors or Applicants of PDUFA Products." This draft guidance outlines the recommendations to industry on formal meetings between the FDA and sponsors or applicants relating to the development and review of new drug or biological drug products. This draft guidance replaces the guidance "Formal Meetings Between the FDA and Sponsors or Applicants of PDUFA Products" issued on December 29, 2017. 2023-09-22 2023 9 https://www.federalregister.gov/documents/2023/09/22/2023-20592/formal-meetings-between-the-food-and-drug-administration-and-sponsors-or-applicants-of-prescription https://www.govinfo.gov/content/pkg/FR-2023-09-22/pdf/2023-20592.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and Drug Administration 221,199 The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled "Formal Meetings Between the FDA and Sponsors or Applicants of PDUFA Products." This draft guidance outlines the recommendations...  

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