federal_register: 2014-22513

All Federal Register documents (rules, proposed rules, notices, presidential documents) from 1994 to present. Nearly 1M documents with full-text search.

Data license: Public Domain (U.S. Government data) · Data source: Federal Register API & Regulations.gov API

This data as json

document_number title type abstract publication_date pub_year pub_month html_url pdf_url agency_names agency_ids excerpts
2014-22513 Report on the Standardization of Risk Evaluation and Mitigation Strategies; Availability Notice The Food and Drug Administration (FDA) is announcing the availability of a draft report entitled "Standardizing and Evaluating Risk Evaluation and Mitigation Strategies (REMS)". This report describes the Agency's findings concerning strategies to standardize risk evaluation and mitigation strategies (REMS), where appropriate, with the goal of reducing the burden of implementing REMS on practitioners, patients, and others in various health care settings. As part of the reauthorization of the Prescription Drug User Fee Act (PDUFA), FDA has committed to standardizing REMS to better integrate them into the existing and evolving health care system. FDA is publishing this report to allow the public to provide comment on the report as it relates to PDUFA. 2014-09-23 2014 9 https://www.federalregister.gov/documents/2014/09/23/2014-22513/report-on-the-standardization-of-risk-evaluation-and-mitigation-strategies-availability https://www.govinfo.gov/content/pkg/FR-2014-09-23/pdf/2014-22513.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 report entitled "Standardizing and Evaluating Risk Evaluation and Mitigation Strategies (REMS)". This report describes the Agency's findings concerning strategies to...

Links from other tables