StevenGrossman

FDA and Industry Relations: A Mix of Frustration and Respect

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 …

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Will Increased User Fees Result in a Faster, Safer Approval Process?

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 …

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Beyond Plan B: Scientific Integrity and a Possible 3rd Class of Drugs

Patient access to the emergency hormonal contraceptive “Plan B One-Step” has been one of the most combustible issues ever faced by FDA. It received more attention last week when FDA approved expanded access for adolescents under 17 and HHS Secretary Katherine Sebelius promptly overruled the agency because she found inadequate scientific support for the decision. …

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Animal Research is an NIH issue, not the FDA. Or is it?

The value of animal research in the life sciences is considered an NIH issue. FDA Matters believes that FDA and its stakeholders should be equally involved. Animal research is the vital first step in the development of new medical products. Before any safety or efficacy testing is permitted in humans, FDA must be satisfied with …

Animal Research is an NIH issue, not the FDA. Or is it? Read More »