federal_register: 2011-22373

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document_number title type abstract publication_date pub_year pub_month html_url pdf_url agency_names agency_ids excerpts
2011-22373 Guidance on Positron Emission Tomography Drug Applications-Content and Format for New Drug Applications and Abbreviated New Drug Applications; Availability Notice The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled "PET Drug Applications--Content and Format for NDAs and ANDAs." This document is intended to assist manufacturers of certain positron emission tomography (PET) drugs in submitting new drug applications (NDAs) or abbreviated new drug applications (ANDAs) in accordance with the Federal Food, Drug, and Cosmetic Act (FD&C Act) and FDA regulations. 2011-09-01 2011 9 https://www.federalregister.gov/documents/2011/09/01/2011-22373/guidance-on-positron-emission-tomography-drug-applications-content-and-format-for-new-drug https://www.govinfo.gov/content/pkg/FR-2011-09-01/pdf/2011-22373.pdf Health and Human Services Department; Food and Drug Administration 221,199 The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled "PET Drug Applications--Content and Format for NDAs and ANDAs." This document is intended to assist manufacturers of certain positron emission...

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