See the following -

The $100,000-Per-Year Pill: How US Health Agencies Choose Pharma Over Patients

Fran Quigley | TruthOut | August 5, 2016

Don Reichmuth survived prostate cancer once before, back in 2007, so his physician was concerned when tests recently revealed the cancer had returned. Reichmuth's physician prescribed a drug called enzalutamide, marketed by the Japanese company Astellas Pharma, Inc. under the brand name Xtandi. But when the physician sent the prescription to the pharmacy, the managers of Reichmuth's insurance plan sent back an immediate refusal to approve it. Reichmuth, a retired teacher who lives in Washington State, was puzzled by the logic. Then he learned the price of the Xtandi prescription: over $9,700 each month...

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CDISC for Medical Device Companies: Progress Made and Best Practices from Pharma/Biotech Implementation

Event Details
Open Source Event
October 9, 2013 - 6:30pm - 9:00pm
Capgemini Offices, South San Francisco
20425 Stevens Creek Blvd
Cupertino, CA 95014
United States

The healthcare industry, as well as regulatory bodies, have been hard at work in the standardization of clinical trial data. The need for data transparency, traceability, and auditability has continued to increase, in line with the cost of studies and the amount of data submitted to the FDA. As a result, much progress has been made in the past decade in creating standards to ease data exchange and interoperability as well as speed up the regulatory review process.

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