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
All the vaccines being developed for COVID-19 need to be kept at ultra-low temperatures and have very short shelf-lives raising a logistical nightmare for vaccinating millions of individuals in a short time, as desired for the pandemic. The approval of a vaccine is not the end of the pandemic, far from it. While the vaccine … Read more
Since FDA effectively stopped auditing manufacturers six months ago due the pandemic, no company has been found to be non-compliant. Whether this means lax enforcement or more compliant manufacturing is open to debate. It should be noted that up until 10th March, FDA had conducted 231 inspections, and issued 7 Warning Letters in about 2 … Read more
This week CEOs of nine biotech companies publicly pledged that they will not file for FDA approval or emergency authorization for their Covid vaccines unless they meet FDA’s established standards but this pledge may be hard to hold in the current circumstances. It is an odd pledge as it states the obvious; companies do not … Read more
