At Dx Conference, FDA's Gutierrez Sheds Further Light on Plans for Risk-Based LDT Regulation
September 07, 2011
At Dx Conference, FDA's Gutierrez Sheds Further Light on Plans for Risk-Based LDT Regulation
Full-text access for premium subscribers only.
Existing premium subscribers login here.
New to GenomeWeb? Register here quickly.
New to GenomeWeb? Register here quickly.
Related Stories
- Amid 'Chaos,' FDA's Gutierrez Offers Insights on Agency's Regulatory Stance on Molecular Tests
February 13, 2013 / Pharmacogenomics Reporter - FDA Draft Guidance on RUO/IUO Products Proposes Tough Changes for Industry Players
June 8, 2011 / Pharmacogenomics Reporter - FDA's Lesko Provides Update on Personalized Medicine Efforts; Three Guidances Slated for Release
November 30, 2010 / Pharmacogenomics Reporter - FDA Keeping All Ideas in Play in Soliciting Public Comments on LDT Regulation
July 21, 2010 / Pharmacogenomics Reporter - FDA Shelves IVDMIA Final Guidelines in Order to Focus on Overall LDT Regulation
June 23, 2010 / Pharmacogenomics Reporter