We found a match
Your institution may have access to this item. Find your institution then sign in to continue.
- Title
Response to the Proposed Food and Drug Administration Regulation of Laboratory- Developed Tests: It Is Past Time for Professional Consensus.
- Authors
Konnick, Eric Q.
- Abstract
The author reflects on a draft regulatory guidance document released by the U.S. Food and Drug Administration (FDA) which outlines its plan to regulate laboratory-developed tests (LDTs). Topics include some of the reasons cited by laboratory and public health professionals for opposing the guidance such as limiting patient access and the author's thought about the lack of FDA's understanding on the roles of laboratory and pathology professionals in public health as it finalized the guidance.
- Subjects
LABORATORIES -- Law &; legislation; UNITED States. Food &; Drug Administration; CLINICAL chemistry laboratories; LABORATORY equipment &; supplies; CLINICAL pathology
- Publication
Journal of Applied Laboratory Medicine, 2016, p239
- ISSN
2475-7241
- Publication type
Article
- DOI
10.1373/jalm.2016.020909