Comments by Dr. Gary A. Puckrein on the Food and Drug Administration’s FDASIA Section 907 Action Plan October 20, 2014
The National Minority Quality Forum (The Forum) commends the Food and Drug Administration upon the release of the FDA Action Plan to Enhance the Collection and Availability of Demographic Subgroup Data, which is mandated by Section 907 of the 2012 Food and Drug Administration Safety and Innovation Act (FDASIA). The Forum welcomes this next chapter in FDA’s commitment […]
Clinical Research Versus Medical Treatment
FDA: 8/5/14 What is clinical research? Clinical research refers to studies in which people participate as patients or volunteers. Different terms are used to describe clinical research, including: clinical studies clinical trials studies research trials protocols. Clinical research may have a number of goals, such as: developing new treatments or medications identifying causes of illness studying […]
Personalized Medicine and Companion Diagnostics Go Hand-in-Hand
FDA: 7/31/14 Personalized medicine is an evolving field of medicine in which treatments are tailored to the individual patient. You may have a condition, for example, that is caused by a mutation in your genes. With advances in personalized medicine, you might be prescribed a medication that targets that specific mutation. To learn which patients […]
Publication of Pivotal Efficacy Trials for Novel Therapeutic Agents Approved Between 2005 and 2011
JAMA: July 28, 2014 Pivotal efficacy trials, which are trials that form the basis of the US Food and Drug Administration’s (FDA) decision to approve a novel therapeutic agent,1 have great relevance to clinical practice because when these therapies are first approved for use, few clinical trials have been conducted. However, studies focused on pharmacotherapies approved prior to 2005 […]
Accumulating Research: A Systematic Account of How Cumulative Meta-Analyses Would Have Provided Knowledge, Improved Health, Reduced Harm and Saved Resources
PLOS: July 28, 2014 Abstract Background “Cumulative meta-analysis” describes a statistical procedure to calculate, retrospectively, summary estimates from the results of similar trials every time the results of a further trial in the series had become available. In the early 1990s, comparisons of cumulative meta-analyses of treatments for myocardial infarction with advice promulgated through medical textbooks […]
Biopharmaceutical Industry Committed to Discovery and Development of New Therapies for Patients Despite Challenges
Pharma: 07.25.14 Mental health conditions affect 1 in 4 Americans and take a heavy economic toll on the United States. Efforts to find effective treatments for conditions such as anxiety, depression, schizophrenia and substance abuse disorders continue despite difficult hurdles and setbacks. Researchers face a number of challenges in finding new treatments for mental illnesses — including […]
FDA Sentinel: Catching Biopharmaceutical Sponsors by Surprise
Applied Clinical Trials Online: Jul 24, 2014 The FDA has always been concerned about the safety of patients, and they strongly believe that clinical trials are not sufficient to capture all drug related adverse effects. During an update on The Future of FDA’s Drug Safety Program,Andrew C. von Eschenbach stated, “The full magnitude of some potential […]
