federal_register: 2014-04560
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 2014-04560 | Revised Draft Guidance for Industry on Distributing Scientific and Medical Publications on Unapproved New Uses-Recommended Practices; Availability | Notice | The Food and Drug Administration (FDA) is announcing the availability of a revised draft guidance for industry entitled "Distributing Scientific and Medical Publications on Unapproved New Uses--Recommended Practices." This draft guidance revises the final guidance titled "Good Reprint Practices for the Distribution of Medical Journal Articles and Medical or Scientific Reference Publications on Unapproved New Uses of Approved Drugs and Approved or Cleared Medical Devices" published in January 2009. The revised draft guidance provides guidance on FDA's current thinking on recommended practices for drug or medical device manufacturers and their representatives to follow when distributing to health care professionals or health care entities scientific or medical journal articles, scientific or medical reference texts, or clinical practice guidelines ((CPGs); all three collectively referred to as "scientific and medical publications") that discuss unapproved new uses for approved drugs or approved or cleared medical devices marketed in the United States. | 2014-03-03 | 2014 | 3 | https://www.federalregister.gov/documents/2014/03/03/2014-04560/revised-draft-guidance-for-industry-on-distributing-scientific-and-medical-publications-on | https://www.govinfo.gov/content/pkg/FR-2014-03-03/pdf/2014-04560.pdf | Health and Human Services Department; Food and Drug Administration | 221,199 | The Food and Drug Administration (FDA) is announcing the availability of a revised draft guidance for industry entitled "Distributing Scientific and Medical Publications on Unapproved New Uses--Recommended Practices." This draft guidance revises the... |