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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

This week, Pfizer’s announcement that its Covid vaccine is 90% effective upended the path to market for all other vaccines in development. There are 10 other vaccines currently in Phase 3 clinical trials; additionally there are 14 in Phase 2, and 38 in Phase 1 clinical trials worldwide, all of which have a new world … Read more

Manufacturers paying prescribers to encourage preferred prescriptions is an unethical practice barred by most codes of ethics since it is effectively bribing physicians to influence their medical decisions. The Sunshine Act, 2010, requires manufacturers to disclose all payments made to physicians in any form with an intent to discourage such practice. The law created a … Read more

The FDA approval of Remdesivir carried another incentive for Gilead granted to anyone developing a product to treat or prevent Covid, the Priority Review Voucher (PRV), which is potentially worth hundreds of millions of dollars. This is the second PRV for a Covid product and practically every Covid vaccine and treatment developer would be eligible … Read more

As telemedicine and virtual care increasingly become the norm for most patient-doctor interactions, FDA does not have any rules or standards for it. FDA treats telemedicine as similar to videoconferencing or teleconferencing interactions between patients and their providers, and as such does not intend to regulate the tools used for telemedicine. On the positive side, … Read more