federal_register: 2013-07445

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2013-07445 Draft Guidance for Industry on Formal Meetings Between FDA and Biosimilar Biological Product Sponsors or Applicants; Availability Notice The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled "Formal Meetings Between the FDA and Biosimilar Biological Product Sponsors or Applicants." This draft guidance provides recommendations to industry on formal meetings between FDA and sponsors or applicants relating to the development and review of biosimilar biological products regulated by the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER). The guidance assists sponsors and applicants in generating and submitting a meeting request and the associated meeting package to FDA for biosimilar biological products. 2013-04-01 2013 4 https://www.federalregister.gov/documents/2013/04/01/2013-07445/draft-guidance-for-industry-on-formal-meetings-between-fda-and-biosimilar-biological-product https://www.govinfo.gov/content/pkg/FR-2013-04-01/pdf/2013-07445.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Food and Drug Administration 221,199 The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled "Formal Meetings Between the FDA and Biosimilar Biological Product Sponsors or Applicants." This draft guidance provides recommendations to...  

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