The legal environment for precision medicine

Clinical Pharmacology and Therapeutics

Volumn 99, Issue 2, 2016, Pages 167-169

  Thompson, B ^a   Boiani, J ^a  

^a Epstein Becker and Green's   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

VACCINE;

ACT; CELL THERAPY; CLINICAL LABORATORY; COMPACT DISK; COMPUTER PROGRAM; DECISION SUPPORT SYSTEM; DIGITAL IMAGING; DRUG FORMULATION; EMBRYONIC STEM CELL; FOOD AND DRUG ADMINISTRATION; GENE THERAPY; GOVERNMENT REGULATION; HUMAN; IMMUNOTHERAPY; MEDICOLEGAL ASPECT; MOBILE APPLICATION; NATIONAL HEALTH ORGANIZATION; PERSONALIZED MEDICINE; PRIORITY JOURNAL; REVIEW; THREE DIMENSIONAL PRINTING; WORKSHOP; TRENDS; UNITED STATES;

HUMANS; LEGISLATION, MEDICAL; MOBILE APPLICATIONS; PRECISION MEDICINE; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 84970917673     PISSN: 00099236     EISSN: 15326535     Source Type: Journal    
DOI: 10.1002/cpt.303     Document Type: Review

References (10)

1. FDA, List of Cleared or Approved Companion Diagnostic Devices (In Vitro and Imaging Tools) (last updated Aug. 13, 2015) .
2. FDA, Laboratory Developed Tests (last updated Nov. 21, 2014) .
3. FDA, FDA Notification and Medical Device Reporting for Laboratory Developed Tests (LDTs) (Draft Guidance for Industry, Food and Drug Administration Staff, and Clinical Laboratories) (published online October 2014) .
4. Basulto, D. Why it Matters that the FDA Just Approved the First 3D-Printed Drug, Washington Post (published online 11 August 2015) .
5. FDA, Public Workshop - Mobile Medical Applications Draft Guidance, September 12-13, 2011 (last updated Mar. 13, 2014), .
6. FDA, General Wellness: Policy for Low Risk Devices (Draft Guidance for Industry and Food and Drug Administration Staff) (published online January 2015) .
7. NIH. Precision Medicine Initiative: Building a Large U.S. Research Cohort (NIH Workshop Executive Summary) (published online February 2015) .
8. FDA. CDRH Fiscal Year 2015 (FY 2015) Proposed Guidance Development and Focused Retrospective Review of Final Guidance (last updated Feb. 20, 2015) .
9. Bowman, D. Revamped MEDTECH Act Looks to Exempt Low-Risk Software from FDA Guidance, FierceHealthIT (published online 28 April 2015) .
10. House Committee on Energy and Commerce. The 21st Century Cures Act (HR 6) .