Using FDA Big Data and Electronic Health Records to Improve Drug Safety
Recent research, published in the journal Science Translational Medicine, found a method to help address adverse events from…
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Yearly Archives
2013
Senate Announces Open Executive Session to Discuss Repeal of SGR
Senate Finance Committee Chairman Max Baucus (D-MT) today announced an Open Executive Session on December 12th at 10am ET to…
Physician Payment Sunshine Act: Open Payments Webinar CMS Avoids Hard…
The Centers for Medicare and Medicaid Services (CMS) provided two webinar sessions on Open Payments, the CMS program to implement…
FAQ’s on Repealing the Medical Device Tax
When we previously reported on the IRS Medical Device Tax Final Rule in January 2013, we noted that there was growing bipartisan…
CMS Soliciting Comments on QHP Quality Rating System
The Centers for Medicare and Medicaid Services (CMS) issued a notice with comment yesterday, officially scheduled to be published…
CMS Medicare Self-Referral Disclosure Protocol
The Centers for Medicare and Medicaid Services (CMS) published the Medicare Self-Referral Disclosure Protocol (SRDP) pursuant to…
Physician Payment Sunshine Act: Open Payments May Cause Physicians to…
Under the Physician Payments Sunshine Act (Open Payments), pharmaceutical companies, medical device manufacturers, and medical…
FDA Clearance of Medical Devices Through 510K (FDA and HHS-OIG Reports)
The U.S. Department of Health and Human Services, Office of Inspector General issued a report: "FDA's Clearance of Medical Devices…
UK Sunshine Act: ABPI Updating Code of Practice to Enhance Transparency in…
Member companies of the Association of the British Pharmaceutical Industry (ABPI) have agreed to amend the ABPI Code of Practice…
FDA: The Differences with Pharmaceutical and Device Promotion Standards
Over the years we have noted in our coverage of FDLI's Enforcement and Litigation Conference that DOJ and other officials…