federal_register: 2018-05688

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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
2018-05688 Immediately in Effect Guidance for Industry; Compliance Policy for Combination Product Postmarketing Safety Reporting; Availability Rule The Food and Drug Administration (FDA or we) is announcing the availability of an immediately in effect guidance for industry entitled "Compliance Policy for Combination Product Postmarketing Safety Reporting." This guidance describes FDA's compliance policy for combination product applicants and constituent part applicants and activities under FDA regulations that addresses combination product postmarketing safety reporting. This guidance is immediately in effect, but it remains subject to comment in accordance with the Agency's good guidance practices. 2018-03-21 2018 3 https://www.federalregister.gov/documents/2018/03/21/2018-05688/immediately-in-effect-guidance-for-industry-compliance-policy-for-combination-product-postmarketing https://www.govinfo.gov/content/pkg/FR-2018-03-21/pdf/2018-05688.pdf Health and Human Services Department; Food and Drug Administration 221,199 The Food and Drug Administration (FDA or we) is announcing the availability of an immediately in effect guidance for industry entitled "Compliance Policy for Combination Product Postmarketing Safety Reporting." This guidance describes FDA's compliance...  

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