Prahsant Kumar

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

FDA announced that in cases it is unable to conduct on-site Pre-Approval Inspections (PAIs), there are four possible outcomes for the applicants. This is to clarify a previous guidance document on the topic released last month. Applicants to plan and strategize accordingly. In a no-PAI situation, FDA may (1) approve the application, (2) issue a … Read more

Lying to FDA is a federal crime punishable by monetary penalties and jail time. We should never have to say that, but occasionally there are cases of people doing it anyway and becoming a warning for others. The case in point is of a team of clinical operations staff at a Florida CRO that fabricated … Read more