federal_register: 2017-26437
Data license: Public Domain (U.S. Government data) · Data source: Federal Register API & Regulations.gov API
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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 |
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| 2017-26437 | Prescription Drug User Fee Act VI Commitment To Assess Current Practices of the Food and Drug Administration and Sponsors in Communicating During Investigational New Drug Development; Establishment of a Public Docket; Request for Comments | Notice | The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the statement of work to assess current practices of FDA and sponsors in communicating during investigational new drug (IND) development and identify best practices and areas of improvement. The independent assessment is part of FDA performance commitments under the recent reauthorization of the Prescription Drug User Fee Act (PDUFA). The independent assessment of current practices of FDA and sponsors in communicating during drug development is described in detail in the document entitled "PDUFA Reauthorization Performance Goals and Procedures Fiscal Years 2018 Through 2022" available at https://www.fda.gov/downloads/forindustry/ userfees/prescriptiondruguserfee/ucm511438.pdf. As part of FDA performance commitments described in this document, the assessment will be conducted by an independent contractor. FDA is providing for public comment on the statement of work before revising and requesting contractor proposals. | 2017-12-08 | 2017 | 12 | https://www.federalregister.gov/documents/2017/12/08/2017-26437/prescription-drug-user-fee-act-vi-commitment-to-assess-current-practices-of-the-food-and-drug | https://www.govinfo.gov/content/pkg/FR-2017-12-08/pdf/2017-26437.pdf | Health and Human Services Department; Food and Drug Administration | 221,199 | The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the statement of work to assess current practices of FDA and sponsors in communicating during investigational new drug (IND) development and identify best... |