federal_register: 2019-15595

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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
2019-15595 Final Guidance for Industry and FDA Staff on Postmarketing Safety Reporting for Combination Products; Availability Notice The Food and Drug Administration (FDA) is announcing the availability of a final guidance for industry and FDA staff entitled "Postmarketing Safety Reporting for Combination Products Guidance for Industry and FDA Staff." The guidance describes and explains the final rule on postmarketing safety reporting (PMSR) for combination products, issued on December 20, 2016, and provides recommendations for complying with the PMSR requirements as well as hypothetical scenarios that illustrate how to comply with certain PMSR requirements. 2019-07-23 2019 7 https://www.federalregister.gov/documents/2019/07/23/2019-15595/final-guidance-for-industry-and-fda-staff-on-postmarketing-safety-reporting-for-combination-products https://www.govinfo.gov/content/pkg/FR-2019-07-23/pdf/2019-15595.pdf Health and Human Services Department; Food and Drug Administration 221,199 The Food and Drug Administration (FDA) is announcing the availability of a final guidance for industry and FDA staff entitled "Postmarketing Safety Reporting for Combination Products Guidance for Industry and FDA Staff." The guidance describes and...  

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