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Despite the media circus around FDA’s approval of Biogen’s Aduhelm, FDA’s decision is legal and permanent. And it will be repeated for other drugs in similar situations. The controversy around this decision is being fueled by misperceptions or misunderstanding of the FDA review process. The regulatory processes and FDA interactions that preceded the FDA decision … Read more

Patient Reported Outcomes (PROs) that capture patient experience data tend to play a central role in FDA decisions about an application when used as primary endpoints in pivotal clinical trials, says a report on FDA’s Patient Focused Drug Development (PFDD) program and its impact on regulatory decisions published last week. PROs are particularly important for … Read more

Suggestions have been made in the media about the impropriety of the process followed by FDA during the review and approval of Biogen’s Aduhelm. While the process followed may not be outrightly illegal, was it ethical, and was it corrupt? It is important to review the facts before we make judgements. The Chief of FDA’s … Read more

Slow and steady does not win the race, at least for the medical product development, as shown by two companies that were slowest of the pack of frontrunners developing Covid vaccines. In both cases, late comers face extreme hurdles to get their products to patients. This week CureVac announced poor clinical trial results with its … Read more

A few years back, Theranos became a harsh example of a Founder/CEO scamming gullible investors with false and misleading science, only to be publicly discredited and gutting of the company. This week we found another company, Athira Pharma, that may have raised almost $300 million based on fraudulent research by its Founder and CEO. Aside … Read more

Many times, we read stories in the mass media about experimental breakthroughs that seems to solve major scientific questions, creating hype around the inventions and companies announcing them. Often hidden from the headlines is the fact these discoveries were made in small animal models and are years, if not decades, from being clinically relevant. This … Read more

Although FDA is not bound to accept the recommendations of its Advisory Committees (Ad Coms), it mostly does. But it is the times when FDA went against the Ad Com, that raises the question, do these committee serve the purpose they were intended? Some of FDA’s most controversial, high-impact decisions in recent times have been … Read more

This week FDA approved Biogen’s new drug for Alzheimer’s disease, Aduhelm, despite getting a no-approval recommendation from its Advisory Committee. FDA has been strongly criticized in the media for this decision, but this is not the first time FDA made such decision and certainly not the last. There are several reasons why if FDA had … Read more

FDA’s self-imposed deadline to remove “enforcement discretion” on stem cell clinics ended last week, with prompt release of consumer announcement and blogs by FDA’s top regulators. However, the exact nature of the removal of enforcement discretion was not made clear. During the enforcement discretion period over the last 3-4 years, FDA issued 400 letters to … Read more

FDA is considering continuing virtual meetings with the sponsor even after the pandemic, announced CDER’s Director, Dr. Patrizia Cavazzoni, at a public meeting last week. Its reasoning that sponsors would find virtual meetings convenient over the hassle of traveling to FDA’s offices, seems to be based on anecdotes rather than formal surveys or any studies. … Read more