The Personalized Medicine Coalition (PMC) has released the results of a public opinion survey, and it is clear that more needs to be done to inform the average U.S. citizen about personalized medicine's benefits.
In a recent letter to the Office of Management and Budget (OMB), the directors of 23 major clinical labs urged OMB to reject FDA's draft guidance on LDT regulation. In this letter, one of the reasons given for rejecting FDA regulation of LDTs is that it would stifle innovation.
Continuing our series of interesting biomarkers to watch in various therapeutic areas we now present 10 biomarkers to watch in the Metabolic and Endocrinology (ME) therapeutic area (see previous posts for Oncology and Cardiovascular).
A letter was sent today to Brian Deese, Acting Director of OMB, by 23 lab directors urging him to withhold FDA's draft guidance regarding LDT regulation. The bases for this resistance are fourfold:
Genetic Engineering News just published a report describing personalized medicine's progress, and it includes the results of a survey of "hundreds of respondents derived from a broad geographic swath ... and broad affiliations."
Target Selection: The Universal Challenge
Five U.S. Senators have signed a letter urging the Office of Management and Budget (OMB) to released a draft guidance on LDT regulation. OMB apparently has 90 days to review regulatory policies but has held the FDA's draft guidance on LDTs "for several years."
We're continuing our series of "Biomarkers to Watch" in different therapeutic areas, and this week's focus is on the Cardiovascular TA.