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Dear Colleagues:

Interesting article below if your work includes clinical research.

-Judith


-Judith Weiner Mills, AHIP, MLIS, MS
Knowledge Manager Librarian
NCNMLG Past President


From the FDA Lawyers Blog:

"On January 22, 2014, the Journal of the American Medical Association ("JAMA") took a closer look at the FDA approval process for drugs and medical devices. On the surface these studies were designed to characterize the type of pivotal data relied on by FDA for approval (or denial) of new drugs and devices. The conclusions from these studies and some of the associated "Opinion" articles suggest, however, that the editors of JAMA, and perhaps its members, believe that FDA should make physicians and patients more acutely aware of the information relied on for new approvals, as well as side effects observed following approval.The main article, entitled "Clinical Trial Evidence Supporting FDA Approval of Novel Therapeutic Agents, 2005-2012", http://www.fdalawyersblog.com/JAMA%20FDA%20approvals.pdf took as a starting point that physicians and patients do not understand or have the tools to evaluate the different strengths of clinical evidence used by FDA
 to approve new drug and device therapies. Based on an Internet-based study, for example, the study reported that a national sample of 4316 adults (68% response rate) found that 39% believe FDA approves only "extremely effective" drugs and 25% only drugs without adverse events, which the authors said may reflect the opinions of some physicians."