iwewlkws 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
The year 2022 was the year when the pandemic came to an end, unofficially at least, but there are many things at FDA that started with the pandemic and changed it for good. While these changes may not affect the core rules, they affect the relationship between the FDA and all the stakeholders in significant … Read more
It should be a moot point that clinical trials cannot be conducted without filing an IND application with the FDA and waiting for the FDA clearance prior to initiating the trial in patients. It also should be a moot point that IRB approval alone is not sufficient to initiate clinical trials with drugs and biologics. … Read more
