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
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
As the pandemic recedes in the US, FDA management seems to be having the same issue practically all managers in the country are facing; do we bring workers back to the offices or keep working remote? It seems FDA is leaning towards keeping it remote. In a public presentation earlier this month, the new Director … Read more
The pandemic necessitated remote clinical trials where almost all the trial activities were done at the home of participants rather than in clinics. Remote clinical trials while being quite efficient and productive raise new questions about data integrity and reliability. How does one monitor data collected and submitted by the patient remotely? Several trial specific … Read more
South Korea was one of the first countries to curtail the spread of Covid infections and bring the pandemic under control. A report by the FDA comparing the responses by the government agencies in the two countries presents starkly different approaches between the two countries despite having similar timelines. While the health agencies in South … Read more
Almost all the products used to diagnose, prevent, and treat Covid infection, in the US, were authorized under the Emergency Use Authorizations (EUA), and now that the pandemic seems to be getting under control, at least in the US, it is critical that manufacturers of these products start thinking of life after the emergency both … Read more
