ICD-10 Update: Conversion Finally Getting Testing but Program Will Be…
On October 1, 2014 of this year CMS is requiring all providers and health systems to submit their bills using a new coding system…
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FDA: Policies and Procedures for Proposed Trial Design Aimed at Multiple…
In a recent staff memo, Dr. Robert Temple, Deputy Director for Clinical Science at the FDA's Center for Drug Evaluation and…
Physician Payments Sunshine Act: Open Payments Phase I Registration and…
On Tuesday, February 18th, CMS opened applicable manufacturer registration for phase I for Open Payments, the CMS program to…
US v. Caronia, One Year Later: FDA’s Position on Off-Label Promotion…
The Washington Legal Foundation (WLF) recently presented "US v. Caronia, One Year Later: The First Amendment and Federal Oversight…
Germany Plans To Reveal Rebated Drug Prices
Germany is considering legislation that would force drug companies to report previously private negotiations with insurers.…
Physician Payments Sunshine Act: CMS Open Payments Teleconference to…
The Centers for Medicare and Medicaid Services (CMS) will conduct a webinar to explain requirements for Open Payments, the…
Physician Payments Sunshine Act: Open Payments Registration Now Open?
In Baltimore, home of Centers for Medicare and Medicaid Services (CMS), we awoke to a dusting of additional snow. We also woke…
Lance vs. Wyeth – PA Supreme Court: Pharmaceutical Companies Can Be…
Recently, The Pennsylvania Supreme Court ruled that pharmaceutical companies can be held liable for negligence in the design and…
NIH, Industry and Non-Profits Join Forces to Accelerate Discovery of…
The National Institutes of Health (NIH) announced a partnership with ten drug makers, as well as eight non-profit organizations,…
FDA Office of Regulatory Affairs Operations: Outlines Significant Changes
Last September, we were the first to report on trends relating to changes in leadership at the FDA's Office of Regulatory Affairs.…