A Top Priority in Women’s Health Research: Noninvasive Endometriosis Diagnostics

Development of a noninvasive diagnostic for endometriosis has long been a priority for researchers. For example, a workshop report from the 2011 World Congress of Endometriosis entitled Defining Future Directions for Endometriosis Research noted both the need for a noninvasive diagnostic and the challenge: A noninvasive test for the reliable diagnosis of endometriosis, and in [...]

A Top Priority in Women’s Health Research: Noninvasive Endometriosis Diagnostics 2018-09-19T17:53:55+00:00

An Update on Women’s Unmet Medical Needs: National Women’s Health Week 2018

A post in this blog during National Women's Health Week 2016 discussed six areas of significant unmet medical needs in women's health. This post for National Women's Health Week 2018 provides an update on the status of product development in addressing three of those areas of unmet need. Increased availability of noninvasive diagnostics for health conditions [...]

An Update on Women’s Unmet Medical Needs: National Women’s Health Week 2018 2018-08-14T20:56:42+00:00

The Importance of Pilot Studies in Diagnostics Development

Pilot studies may seem unnecessary when your investigational diagnostic is performing superbly for lab professionals in your internal labs. Why waste time and money on a pilot study when you are witnessing excellent results in the lab day after day? After all, the goal of every development program is to obtain regulatory approval, market the [...]

The Importance of Pilot Studies in Diagnostics Development 2018-08-14T21:00:58+00:00

Webinar: Regulatory Changes and Operational Challenges for Dx Developers

Health Decisions is offering a complimentary webinar December 14, 2017 to assist diagnostics developers in addressing regulatory changes on both sides of the Atlantic and key operational issues such as the transition to subject-based testing. Changes at FDA include faster turnaround times for some diagnostics reviews. In the EU, new Device Directives will require developers [...]

Webinar: Regulatory Changes and Operational Challenges for Dx Developers 2018-08-14T21:01:45+00:00

Women’s Health Week 2017: Spotlight on Infectious Conditions

For National Women's Health Week last year, this blog focused on the need for progress in a variety of areas in which women have unmet medical needs. Last year's post mentioned the need for progress in noninvasive diagnostics and therapeutics for osteoporosis, female sexual dysfunction, endometriosis, bacterial vaginosis and uterine fibroids. This year we want [...]

Women’s Health Week 2017: Spotlight on Infectious Conditions 2018-08-14T21:06:25+00:00

Differences Between Drug and Medical Device Trials: CSRs

While drugs and medical devices are both essential in modern medical care, there are times when standard clinical development processes seem to treat medical devices as an afterthought. For example, medical writers for a CRO conducting studies of both drugs and devices must learn to interpret a drug-centric guidance document to author an appropriate Clinical [...]

Differences Between Drug and Medical Device Trials: CSRs 2018-08-14T21:07:18+00:00

Settling on a Framework for LDT Regulation: Update

Update: The FDA post-election statement on delaying implementation of the agency's draft guidance on LDTs affirms the status quo - for now. The delay allays the concerns of some stakeholders about potential effects of greater FDA involvement in LDT regulation, such as slowing innovation in diagnostics and patient access to the most advanced diagnostics and, [...]

Settling on a Framework for LDT Regulation: Update 2018-08-14T21:10:39+00:00

Prospective IVD Trials: When Are They Necessary?

IVD developers sometimes find it surprising that it is not enough to demonstrate the analytic validity of a test - the ability of the test to determine whether what it is designed to detect is present or absent. IVD developers may expect existing scientific knowledge and a series of informed inferences to connect the dots [...]

Prospective IVD Trials: When Are They Necessary? 2018-08-14T21:12:52+00:00

Women’s Health Week: Highlighting Unmet Medical Needs

Significant unmet medical needs profoundly affect the lives of hundreds of millions of women worldwide. Women have more than their fair share of healthcare needs for a variety of reasons, including: Women’s healthcare needs vary substantially over the life cycle, from childhood and adolescence through the childbearing years and menopause; this increases the challenge for [...]

Women’s Health Week: Highlighting Unmet Medical Needs 2018-08-14T21:15:13+00:00

Key Issues in Coordinating Drug and CDx Development

Companion diagnostics (CDx) are IVDs developed for the purpose of identifying a characteristic that increases the likelihood of patient responsiveness to a specific treatment. Companion diagnostics will take on increasing importance with the growth of precision medicine. Some aspects of the future of dedicated companion diagnostics are unclear as understanding of complex disease mechanisms increases, [...]

Key Issues in Coordinating Drug and CDx Development 2018-08-14T21:15:54+00:00
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