Prahsant Kumar

In the first Guidance Document of 2021, FDA emphasized a very important procedural aspect of sponsor-FDA meetings arising from the sponsor inviting outside parties to such meetings. FDA warns that bringing an outside party to a sponsor-FDA meeting could potentially compromise the confidentiality of the information discussed at the meeting unless the sponsor took legal … Read more

It seems like stating the obvious, but the pandemic will have some long-term negative effects on the FDA-regulated industry at least for the next few years which would tangibly and perceptively affect new product development and healthcare. Here we list five that seem most obvious to us. First, there is a huge backlog of clinical … Read more

As the year of the worst pandemic in modern times comes to an end, it is time to reflect on five major changes in drug development and healthcare, that are here to stay for good. To be fair these are less of changes and more of appreciation of what existed before but was used less … Read more

Proprietary names of drugs and biologics are valuable for building the brand recognition and medication preferences of doctors and patients alike. To emphasize the importance of appropriate proprietary names, also called Brand names, of both prescription and non-prescription drugs and biologics, FDA this week released two Guidance Documents to describe the expected practices for drug … Read more

Gut microbiome has been suggested to be linked to several diseases seemingly unrelated to the digestive system with the scientific literature rife with anecdotes and poorly designed studies. A report published this week provides a novel approach to establish microbiome-disease relationship that, in turn, could provide a scientific strategy to generate critical data for regulatory … Read more

With the news of two vaccines likely getting authorization in the next week or two, volunteers for other vaccine trials are getting scant. In a news this week, several volunteers in the control groups in other vaccine trials expressed interest to get the approved vaccines as soon as they become available. This could make completing … Read more

With UK approving the Pfizer Covid vaccine this week, there is increased pressure on FDA to be the next regulatory agency to do the same, which could be as early as next week. Historically, European and US regulators have routinely raced to be the first to approve well publicized new treatments. Covid vaccines fit that … Read more

Mobile apps and wearable devices that track general health related information such as mobility, temperature, blood pressure pose little or no risk to the users and significantly improve healthy lifestyles, FDA reports in an analysis released this week. General health awareness software such those associated with common use wearable devices such as smart watches are … Read more

This week with Moderna announcing a 95% effective vaccine and Pfizer updating its numbers from last week claiming that their vaccine too is similarly effective, we have two good candidates, both using the same mechanism of action. Previously Russia and China had announced that their adenovirus-based vaccines were also more than 90% effective. It seems … Read more

While it is well known that FDA accepts clinical trial data from anywhere so long as it meets certain quality standards, the full extent of the impact of this policy comes out in a report released by FDA this week. According to the report, almost 90% of the clinical data that was used for approval … Read more