federal_register: 2020-26700

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document_number title type abstract publication_date pub_year pub_month html_url pdf_url agency_names agency_ids excerpts
2020-26700 Requesting FDA Feedback on Combination Products; Guidance for Industry and FDA Staff; Availability Notice The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry and FDA staff entitled "Requesting FDA Feedback on Combination Products." The purpose of this guidance is to discuss ways in which combination product sponsors can obtain feedback from FDA on scientific and regulatory questions and to describe best practices for FDA and sponsors when interacting on these topics. These interactions can occur through application-based mechanisms, such as the pre-submission process used in the Center for Devices and Radiological Health (CDRH) and the Center for Biologics Evaluation and Research (CBER) and the formal meetings used in the Center for Drug Evaluation and Research (CDER) and CBER, or through Combination Product Agreement Meetings (CPAMs), as appropriate. 2020-12-04 2020 12 https://www.federalregister.gov/documents/2020/12/04/2020-26700/requesting-fda-feedback-on-combination-products-guidance-for-industry-and-fda-staff-availability https://www.govinfo.gov/content/pkg/FR-2020-12-04/pdf/2020-26700.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 final guidance for industry and FDA staff entitled "Requesting FDA Feedback on Combination Products." The purpose of this guidance is to discuss ways in which...

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