federal_register: 2016-08899

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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
2016-08899 Radiation Biodosimetry Medical Countermeasure Devices; Guidance for Industry and Food and Drug Administration Staff; Availability Notice The Food and Drug Administration (FDA or Agency) is announcing the availability of the guidance entitled "Radiation Biodosimetry Medical Countermeasure Devices." FDA has developed this guidance to provide industry and Agency staff with recommendations for the types of information that should be submitted to support marketing authorization for radiation biodosimetry medical countermeasure devices. 2016-04-18 2016 4 https://www.federalregister.gov/documents/2016/04/18/2016-08899/radiation-biodosimetry-medical-countermeasure-devices-guidance-for-industry-and-food-and-drug https://www.govinfo.gov/content/pkg/FR-2016-04-18/pdf/2016-08899.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 guidance entitled "Radiation Biodosimetry Medical Countermeasure Devices." FDA has developed this guidance to provide industry and Agency staff with recommendations...  

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