federal_register: 2018-25128

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document_number title type abstract publication_date pub_year pub_month html_url pdf_url agency_names agency_ids excerpts
2018-25128 Report on the Performance of Drug and Biologics Firms in Conducting Postmarketing Requirements and Commitments; Availability Notice The Food and Drug Administration (FDA or Agency) is announcing the availability of the Agency's annual report entitled "Report on the Performance of Drug and Biologics Firms in Conducting Postmarketing Requirements and Commitments." Under the Federal Food, Drug, and Cosmetic Act (FD&C Act), FDA is required to report annually on the status of postmarketing requirements (PMRs) and postmarketing commitments (PMCs) required of, or agreed upon by, application holders of approved drug and biological products. The report on the status of the studies and clinical trials that applicants have agreed to, or are required to, conduct is on the FDA's "Postmarketing Requirements and Commitments: Reports" web page (https://www.fda.gov/Drugs/ GuidanceComplianceRegulatoryInformation/Post- marketingPhaseIVCommitments/ucm064436.htm). 2018-11-19 2018 11 https://www.federalregister.gov/documents/2018/11/19/2018-25128/report-on-the-performance-of-drug-and-biologics-firms-in-conducting-postmarketing-requirements-and https://www.govinfo.gov/content/pkg/FR-2018-11-19/pdf/2018-25128.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 the Agency's annual report entitled "Report on the Performance of Drug and Biologics Firms in Conducting Postmarketing Requirements and Commitments." Under the Federal...

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