22:39 , Sep 5, 2018 |  BC Extra  |  Politics & Policy

FDA takes steps to bring diagnostics to patients faster

FDA Commissioner Scott Gottlieb highlighted steps the agency is taking to speed patient access to new medical devices, such as diagnostics, and laid out its framework for review of premarket approval applications (PMAs). Gottlieb unveiled...
19:32 , Jun 15, 2017 |  BC Extra  |  Politics & Policy

Gottlieb: FDA taking regulatory steps to promote digital health tech

In a blog post Thursday, FDA Commissioner Scott Gottlieb outlined regulatory steps designed to promote development of digital health technologies. The agency intends to issue new guidance that would clarify FDA's regulatory scope in the...
07:00 , Sep 7, 2015 |  BioCentury  |  Strategy

Back to School: Changing the subject

No longer content with a walk-on role as research subjects, and empowered by access to more information and the necessity of shouldering a bigger share of the healthcare bill, patients are demanding a speaking role...
07:00 , Jun 29, 2015 |  BioCentury  |  Product Development

Would you rather?

Medical product developers, regulators and patients are starting to apply social science to life science, using techniques created to measure the preferences of individuals and groups to shape how medicines are designed, tested, regulated and...
01:56 , May 14, 2015 |  BC Extra  |  Politics & Policy

CDRH releases patient-preference guidance

FDA's Center for Devices and Radiological Health (CDRH) on Wednesday released (see BioCentury, Feb. 23). Separately, the Medical Device Innovation Consortium (MDIC), a public-private partnership, released a report Wednesday entitled "A Framework for Incorporating Information...
08:00 , Feb 23, 2015 |  BioCentury  |  Politics, Policy & Law

Calming the pendulum

Regulators and drug developers have converged on the idea that enhancing and broadening patient engagement is a key to improving drug development and adjudicating controversies over benefit-risk decisions and the value of medicines. While...
08:00 , Dec 10, 2012 |  BC Week In Review  |  Company News

LifeScience Alley other news

LifeScience, a biomedical science trade association, created the Medical Device Innovation Consortium ( MDIC) to speed development and review of medical devices. The non-profit public-private partnership will select and fund projects focused on developing regulatory...
07:00 , Jul 9, 2007 |  BioCentury  |  Tools & Techniques

Early mDIC-ations

Isis Pharmaceuticals Inc. believes it is the first to show preclinical efficacy with a novel obesity target - mitochondrial dicarboxylate carrier (mDIC). Although there are still some questions as to exactly how it elicits its...