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To Outsource or Not To Outsource? That May No Longer Be a Question

The healthcare landscape is changing dramatically… and many changes are yet to come. As such, outsourcing has increased in an effort to drive down cost and comply with the ever-changing regulatory environment.   Here are 4 outsourcing trends in the pharmaceutical and healthcare industries: Crisis Management Recall Support: During any given recall, the need to…

Adverse Event Data

Earlier this year FDA announced that it is planning to make access to much of its structured data, including the adverse event data in its safety database FAERS, available more easily to the public. Dr. Taha Kass-Hout, the Chief Health Informatics Officer of FDA wrote on the website that FDA is developing an initiative…


Off-Label Use & Safety

There has been a lot of discussion regarding the off-label use of drugs.  This has been a focus of interest for FDA, EMA, MHRA and other health agencies around the world and certainly has been an issue and concern at companies over the years.  This is a complex issue with implications for public health, patient…

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Safety Items in the News

Several safety items have been in the news recently and are summarized here. Direct-To-Consumer Safety In February the FDA published a notice in the Federal Register (see: entitled: “Disclosure Regarding Additional Risks in Direct-to-Consumer (DTC) Prescription Drug Television Advertisements”.   The FDA is requesting comments within 60 days. This is a proposed study on direct…

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DIA’s “What Lies Ahead” Document

The Drug Information Association has just released an interesting document entitled “What Lies Ahead 2014: Trends to Watch: Medical Product Development in North America” It is a short review focusing on 10 trends (actually 11 as two trends are tied for tenth place) identified by thought leaders dealing with drug products from industry, academe,…