federal_register: 2020-16016

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document_number title type abstract publication_date pub_year pub_month html_url pdf_url agency_names agency_ids excerpts
2020-16016 Annual Summary Reporting Requirements Under the Right to Try Act Proposed Rule To facilitate implementation of the reporting requirements of the Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina Right to Try Act of 2017 (Right to Try Act), the Food and Drug Administration (FDA, the Agency, or we) is proposing to establish requirements for the deadline and contents of submission of an annual summary. This proposed rule, if finalized, would implement the statutory requirement under provisions of the Right to Try Act for submission of an annual summary by sponsors and manufacturers who provide an eligible investigational drug for use by an eligible patient. 2020-07-24 2020 7 https://www.federalregister.gov/documents/2020/07/24/2020-16016/annual-summary-reporting-requirements-under-the-right-to-try-act https://www.govinfo.gov/content/pkg/FR-2020-07-24/pdf/2020-16016.pdf Health and Human Services Department; Food and Drug Administration 221,199 To facilitate implementation of the reporting requirements of the Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina Right to Try Act of 2017 (Right to Try Act), the Food and Drug Administration (FDA, the Agency, or we) is proposing...

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