federal_register: 2012-3549

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document_number title type abstract publication_date pub_year pub_month html_url pdf_url agency_names agency_ids excerpts
2012-3549 Draft Guidance for Industry on Biosimilars: Questions and Answers Regarding Implementation of the Biologics Price Competition and Innovation Act of 2009; Availability Notice The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled "Biosimilars: Questions and Answers Regarding Implementation of the Biologics Price Competition and Innovation Act of 2009." This draft guidance is intended to provide answers to common questions from sponsors interested in developing proposed biosimilar products, biologics license application (BLA) holders, and other interested parties regarding FDA's interpretation of the Biologics Price Competition and Innovation Act of 2009 (BPCI Act). 2012-02-15 2012 2 https://www.federalregister.gov/documents/2012/02/15/2012-3549/draft-guidance-for-industry-on-biosimilars-questions-and-answers-regarding-implementation-of-the https://www.govinfo.gov/content/pkg/FR-2012-02-15/pdf/2012-3549.pdf Health and Human Services Department; Food and Drug Administration 221,199 The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled "Biosimilars: Questions and Answers Regarding Implementation of the Biologics Price Competition and Innovation Act of 2009." This draft...

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