Diagnostics and the Evolution of the FDA: Mya Thomae, MyraqaSubmitted by Theral Timpson on Mon, 12/10/2012 - 12:52
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Mya Thomae, Founder and CEO, Myraqa Bio and Contact Info
Listen (9:22) What's least understood about the regulation of diagnostics?
Listen (2:22) How well is the FDA evolving from the old blockbuster drug model?
Listen (6:58) Regulatory advice fo diagnostics developers
Listen (9:32) How do you see the LDT issue playing out?
Listen (5:12) Are diagnostics way undervalued?
Listen (2:24) From music performance to regulatory affairs
Mya Thomae is an expert in the regulation of in vitro diagnostics. On today's show, she shares with us the advice that she gives her clients seeking FDA approval for their diagnostic products. Mya weighs in on the issue of LDTs: the FDA says it has the authority to regulate LDTs, but so far has issued no draft guidance. This is creating an unfair playing field for those producing CoDx, which are regulated. Has the FDA been waiting for the election to issue guidance? Does Obama's reelection or the recent 'Spygate' and meningitis outbreak really affect the FDA? Ms. Thomae travels often to Washington and offers her informed views.