iwewlkws 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
Regeneron filed for an EUA for its antibody cocktail for COVID-19 within days of it being used to treat President Trump. While emergency use authorizations based on data from a few patients are not uncommon, the timing of this application and the immediate public authorization by the President creates an impression that Regeneron is trying … Read more
Last week FDA proposed new rules for food traceability that would require manufacturers, processors, packers, storage companies and distributors to maintain detailed records regarding growing, receiving, creating, transforming and shipping certain foods on the newly created Food Traceability List (FTL). The goal of these rules is to allow rapid mitigation of food borne illness outbreaks … Read more
Soon ANDA applications for generic drugs will not be able to go through multiple review cycles due to the applicants taking too long to respond to the deficiencies identified by FDA. This week FDA released a new guidance that sets strict timeline of 1 year to respond to deficiencies with a goal to eliminate arbitrary … Read more
This week FDA announced a new Digital Health Center of Excellence within CDRH with an explicit mandate to provide advice and support to developers of digital health products. The Center would consolidate FDA resources to create policies and support infrastructure for review of software and digital health products, address cybersecurity issues, evaluate tools based on … Read more
FDA enforcement officials would have to reach a higher standard of evidence for accusing a manufacturer for off-label promotion. This week FDA released a new rule describing a wholistic approach to assess the intent of a manufacturer to promote new uses of a previous-approved product thereby creating flexibility in enforcement of marketing practices unlike any … Read more
Cannabis products manufactured for non-FDA regulated purposes can also be used to develop pharmaceutical products. However, most cannabis products are manufactured using proprietary methods which the manufacturers would not share with pharmaceutical developers. In an email this week, FDA advised such manufacturers to file Drug Master Files (DMFs) that could be used to help drug … Read more
