Resources

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 Potions and procedures of dubious value have been replaced by powerful medicines that treat infections, heart disease, diabetes and mental illness.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, […]

Johnson and Johnson gutted and retooled their Fort Washington facility to come back with a bang with the launch of a new bottle designed for its grape flavored infant liquid Tylenol to guard against accidental overdosing. But instead of accolades, complaints poured in about the protective cover pushing loose when the dosing syringe was inserted. […]

The FDA’s search for a more efficient medical device approval process continues full steam ahead with the latest announcement that the Administration is looking to leverage partnerships within the industry in order to achieve this particular goal. Although the relationship is being described as ‘informal,’ the FDA will be working together with Biocom in order […]

In every successful company, the glittery careers and the recognizable names belong to people who develop new products that meet consumer and patient needs. Innovation in new products (and careful husbanding of intellectual property and market share) are what brings in the revenue and determines corporate success. By comparison, there is little recognition and often […]

Improving the efficiency of clinical trials has become one of the most important priorities for pharmaceutical companies around the world.In its annual R&D management report, the Tufts Center for the Study of Drug Development (CSDD) recently estimated the full price of bringing a new drug to market at over $1.3 billion. The report indicated that […]