Resources

There is no question that pharmaceutical companies large and small are feeling the financial pressures associated with deploying large clinical trials. Traditional trial designs can be overly cumbersome and expensive, particularly when applied to large populations of patients over the course of a lengthy investigation. This inescapable fact has lead many investigators toconsider alternative pathways […]

A recent segment on the Today show highlighted public concerns regarding hospital acquired infections – specifically, those that can be contracted from medical devices and surgical instruments. The report presented the case that even if proper sterilization processes are followed, there remains a strong chance that surgical equipment will be contaminated with blood, tissue, and […]

An important part of the 2012user fee reauthorizationcycle is Congressional efforts to push FDA toward approving drugs and biologics more rapidly. Most of industry and a large number of patient groups agree. Proposals to speed up FDA are already in play. Since these proposals have a common purpose, it is easy to think of them […]

FDA Matters’ State of the FDA—January 2012 identified agency funding as the greatest threat to the FDA’s future. The agency received a very small increase in FY 12 appropriated funding, reflecting the severe budgetary pressure on all U.S. federal agencies. That pressure continues and FDA faces potential cuts in FY 13 (starting October 1, 2012). Advocacy by the Alliance […]

The prescription drug (PDUFA) and medical device (MDUFA) user fee programs, which run for 5 years, must be renewed by September 30 of this year (last day of the current fiscal year). House committee staff has just released a 205-page first draft of reauthorization legislation. The Senate has starting releasing drafts on specific issues and has a March […]

My blood boils when I read an article such as the one that appeared in the New York Times yesterday entitledSupply of a Cancer Drug May Run Out Within Weeks, by Gardiner Harris. This is one of many articles that has appeared lately about the mounting crisis of drug shortages across the country. This time […]

Is the pathway to quicker medical device regulatory approval or clearance to be found through the establishment of higher fees on the part of the Food and Drug Administration? It would seem so, given that the FDA has recently announced a new program that will double the amount of the user fees currently paid by the biggest […]

Over the past decade it has become common for some medical device companies to introduce a product to the European market prior to attempting to gain FDA approval and sell the same device in the United States. In some cases, depending on the classification and technology of the device, Europe can provide a quicker route […]

Two events persuaded FDA Matters to write another column on biological complexity and its implications for medical research, drug discovery, and personalized medicine. First was the release of a remarkable study on gene mutations in cancer tumors. It is a stellar and sobering example of how biological complexity confounds our expectations that rapid advances in science will […]

Notwithstanding herbal medicines and the re-emergence of leeches as therapy, it is only in the last 70 years that physicians have had proven medical science to support “the healing arts.” Potions and procedures of dubious value have been replaced by powerful medicines that treat infections, heart disease, diabetes and mental illness. While the benefits are clear, […]