Prahsant Kumar

In its fifth annual report, FDA’s Oncology Center for Excellence (OCE) listed its expectations for modernizing oncology clinical trials. In its sixth year of operations, the OCE wants to move beyond the work it has accomplished so far and focus on patient and physician perspectives for oncology drugs in clinical trials or available currently in … Read more

Last year FDA inspections were down about 20% compared to years prior to 2019, and food facility inspections accounted for more inspections than all other facilities combined. The most common finding at drug and device manufacturing facilities was SOPs not present or not followed. There are a few other important aspects of FDA audits that … Read more

Starting this month, FDA’s staff will return to their offices in White Oak, outside Washington DC, to a hybrid work-schedule reversing earlier indications from FDA leaders that work from home may become permanent. While it may seem like a big change in the post-pandemic world, it is not. FDA staff have maintained hybrid work schedules … Read more

Clinical trial sponsors are required to create and implement trial-specific “Race and Ethnicity Diversity Plan” for patient recruitment intended to promote diversity of the subject populations in all stages of their clinical trials. However, these plans have had limited impact on most clinical trials as shown by review of the patient populations included in clinical … Read more

This week’s FDA guidance on the conduct of clinical trials involving cannabis and its derivatives reminds the developers of two critical aspects of the regulation of such products by the FDA and confirms the associated regulatory processes. First, cannabis products containing greater that 0.3 percent delta-9 tetrahydrocannabinol (THC) are still federally regulated as controlled substances … Read more

The FDA recently released an updated clinical protocol template designed for electronic documentation practices. This update provides additional instructions and suggestions for the various elements of clinical protocols to harmonize information needed for electronic information exchanges such as clinical trial registries. The template can be used for all stages of clinical trials for drugs, biologics, … Read more

The Federal Trade Commission (FTC) recently updated its guidance for advertisements for dietary supplements to define several terms commonly used for such products and specify compliance expectations for the supporting information for health claims. The guidance formalizes about 25 years of FTC enforcement actions based on these expectations and is a must-read for dietary supplement … Read more

A recent academic study found, surprisingly (pun intended), that paying people $500 to participate in a study that involved shipping self-collected blood samples to a lab and answering a short questionnaire, led to almost everybody participating compared to when no compensation was offered. The authors concluded that by offering higher compensation for participation, sponsors can … Read more

At the JPM conference this week, the FDA commissioner stated that he is “100% opposed to offshoring” of clinical trials, basically against sponsors going to other countries for cost savings. This is perhaps one of most myopic views expressed by someone so senior at FDA for many reasons. To be fair, I was not at … Read more

Online pharmacies, particularly those based in other countries, have been a constant headache for the FDA. These pharmacies sell drugs, both approved and non-approved to the US consumers and there is practically nothing FDA can do about it as is highlighted by one of FDA’s first warning letters of the year. The warning letter highlights … Read more