Survey About Personalized Medicine Shows Low Public Awareness

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.

Based on Recent Trends, FDA Regulation of LDTs Could Certainly Adversely Affect Biomarker Test Innovation

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letter to the Office of Management and Budget (OMB), the directors of 23 major clinical labs urged OMB to reject FDA's draft guidance on LDT regulation.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.

10 Biomarkers to Watch in Metabolic and Endocrinology

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).

LDT Regulation is Coming to a Head: Lab Directors Send Letter to OMB Urging Rejection of FDA Draft Guidance

by John Audette | Jul 15, 2014 | LDT Regulation, News, Regulation

A letter was sent today to Brian Deese, Acting Director of OMB, by 23 lab directors urging him to withhold FDA's draft guidance regarding LDT regulation.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:

Increased Clinical Trial Speed, and Decreased Adverse Events, Primary Drivers in Personalized Medicine

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."

Mining Clinical Trials for Marketing and Product Development Opportunities

Target Selection: The Universal Challenge

Senators Urge OMB to Release FDA's Draft Guidance on LDTs

by John Audette | Jul 03, 2014 | LDT Regulation, News, Regulation

Five U.S. Senators have signed a letter urging the Office of Management and Budget (OMB) to released a draft guidance on LDT regulation. OMB apparently has 90 days to review regulatory policies but has held the FDA's draft guidance on LDTs "for several years."

10 Biomarkers to Watch in Cardiovascular

We're continuing our series of "Biomarkers to Watch" in different therapeutic areas, and this week's focus is on the Cardiovascular TA.




Pharmacovigilance and Safety Biomarkers

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