federal_register: 2021-11216
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 2021-11216 | Procedures for Handling Post-Approval Studies Imposed by Premarket Approval Application Order; Draft Guidance for Industry and Food and Drug Administration Staff; Availability | Notice | The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled "Procedures for Handling Post-Approval Studies Imposed by Premarket Approval Application Order." The existing post-approval studies final guidance, entitled "Procedures for Handling Post-Approval Studies Imposed by PMA Order," was issued in June 2009. This draft guidance is intended to update the 2009 guidance to assist stakeholders with understanding post-approval study requirements imposed as a condition of approval of a premarket approval application (PMA). This draft guidance is not final nor is it in effect at this time. | 2021-05-27 | 2021 | 5 | https://www.federalregister.gov/documents/2021/05/27/2021-11216/procedures-for-handling-post-approval-studies-imposed-by-premarket-approval-application-order-draft | https://www.govinfo.gov/content/pkg/FR-2021-05-27/pdf/2021-11216.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Drug Administration | 221,199 | The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled "Procedures for Handling Post-Approval Studies Imposed by Premarket Approval Application Order." The existing post-approval studies final... |