Posts Tagged “Regulation”
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by Kevin Roche on Friday, July 2, 2010
A critical component of personalized medicine is various molecular diagnostic tests. AHRQ has issued a lengthy report on the state of these tests, examining their quality and clinical utility.
Tags: Government, Medical Care, Personalized Medicine, Regulation
by Kevin Roche on Friday, June 25, 2010
An FDA lawyer posts an excellent summary of potential issues in regard to FDA’s regulation of mobile health devices and services. He suggests that industry adopt a proactive approach of proposing sensible regulations and guidance to FDA.
Tags: FDA, Mobile, Regulation, Telemedicine
by Kevin Roche on Wednesday, May 19, 2010
Direct-to-consumer genetic tests are becoming more prevalent. Pathway Genetics strikes a distribution deal with Walgreens, but draws FDA scrutiny over whether needed regulatory filings have been performed.
Tags: Personalized Medicine, Regulation
by Kevin Roche on Tuesday, March 23, 2010
Many telehealth, ehealth, mhealth, etc. product companies have assumed that their products and services will move easily through the FDA or that they don’t even need to interact with the agency. Recent statements by agency personnel, and handling of certain filings, should be warning that dealing with FDA regulations is not that simple.
Tags: Regulation, Telemedicine
by Kevin Roche on Thursday, October 8, 2009
Having taken heat on drug safety, the FDA has issued a new draft guidance on risk mitigation efforts by drug companies.
Tags: Drugs, Government, Pharmaceutical, Regulation
by Kevin Roche on Thursday, July 16, 2009
Health information technology is being pushed as one of the key methods to improve health care and reduce costs, but government itself has created barriers to its adoption and utility.
Tags: HIT, Medical Care, Regulation
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