federal_register: 2017-20861

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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
2017-20861 Advancement of Emerging Technology Applications for Pharmaceutical Innovation and Modernization; Guidance for Industry; Availability Notice The Food and Drug Administration (FDA or Agency) is announcing the availability of a guidance for industry entitled "Advancement of Emerging Technology Applications for Pharmaceutical Innovation and Modernization." This guidance finalizes the draft guidance issued December 23, 2015, which provides recommendations to pharmaceutical companies interested in participating in a program involving the submission of emerging manufacturing technology. The program is open to companies that intend to include the technology as part of a regulatory submission including an investigational new drug application (IND), original or supplemental new drug application (NDA), abbreviated new drug application (ANDA) or biologic license application (BLA), or application-associated Drug Master File (DMF) reviewed by the Center for Drug Evaluation and Research (CDER), and where that technology meets other criteria described in this guidance. 2017-09-29 2017 9 https://www.federalregister.gov/documents/2017/09/29/2017-20861/advancement-of-emerging-technology-applications-for-pharmaceutical-innovation-and-modernization https://www.govinfo.gov/content/pkg/FR-2017-09-29/pdf/2017-20861.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 a guidance for industry entitled "Advancement of Emerging Technology Applications for Pharmaceutical Innovation and Modernization." This guidance finalizes the draft...  

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