iwewlkws 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
The data needed to support an EUA will be almost identical to that required for a BLA for the Covid vaccines being developed, according to Dr. Peter Marks, Director of CBER, FDA. This is a major shift (read “clarification”) from the public perception of when Covid vaccines may be available in the US. It has … Read more
Inclusion of minorities in Covid vaccine clinical trials is crucial to assure that the vaccine works across racial and ethnic populations but despite the keen interest in Covid vaccines, minorities represent a minor fraction of the trial participants. Companies have had mixed experience recruiting trial participants at educational institutions with predominantly African-American students, offering a … Read more
The pandemic has created unprecedented disruption in all cancer clinical trials but has also forced the sponsors to explore alternate ways to conduct their trials which could have long term positive effects on such trials much after the pandemic, opine FDA’s top experts in an article in the Journal of American Medical Association. The pandemic … Read more
October is the national cybersecurity awareness month and to celebrate it, FDA updated its cybersecurity webpage and created a new Factsheet to dispel several misperceptions about FDA’s role in assuring cybersecurity measure in medical devices. Over the last decade, as networked devices play a significantly larger role in overall health management, and in medical devices, … Read more
