Resources

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 […]

Over the last month, FDA Matters has covered a wide-range of FDA-related topics: the agency, industry, and Congress, as well as medical innovation, user fee reauthorization legislation, food safety and post-market surveillance. The response has been great: FDA Matters has many new readers and I received a number of interesting questions. Today’s column touches on biosimilars, Hatch-Waxman, user fees […]

R&D production in the pharmaceutical industry has fallen more than 70% over the last 15 years, according to a recently published report, “Beyond the Shadow of a Drought: The need for a new mindset in pharma R&D,” by a group of analysts at the Oliver Wyman consulting firm. According to this insightful analysis, the underlying causes have […]

If you are in the business of developing biosimilar products—or thinking about it—then you have to read all three guidance documents published by FDA on February 9, 2012. They provide essential (but not complete) instructions for how to construct and implement a biosimilar development plan. For everyone else,FDA Mattersis providing the short version. Why take […]

There is no one answer to the question: what is the state of FDA-industry relations? FDA Mattershears some say: FDA does what industry asks it to do, the agency is a puppet. Others say that FDA is obstinately blocking industries’ path to new, better and innovative products. Yet others say FDA is misguided at points, but […]

How long should it take to review a medical device for public use? The FDA’s current average, 73 days, is too much time, according to the medical device industry. Patient advocacy groups however, claim the current process is rushed and at times negligent. A safer, faster approval process would certainly benefit everyone, but enhancements cost […]

Starting this week, the House will hold hearings on reauthorizing the drug and medical device user fee programs that fund one-fourth of the agency. While user fees have become largely non-controversial, this “must-pass” legislation is Congress’ opportunity to consider dozens of other FDA issues, some controversial and many time-consuming. During the last user fee reauthorization […]