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
Testing products on oneself to demonstrate their potential is as old as science itself. But self-experimentation maximizes concerns regarding the conflict of interest and bias in reported results making any reports anecdotal at best. So, can one use data from self-experiments to support formal additional clinical trials or even market approval? Self-experimentation is not illegal … Read more
A five-year long fraud by one clinical trial company on eight of its clients that was undetected by most till one of the clients got suspicious and complained to the FDA raises concerns about how clinical trials are audited by sponsors. Last month the Department of Justice charged eight individuals in Ohio with several counts … Read more
FDA’s decision this week to formally authorize COVID-19 convalescent plasma (CCP) as a treatment for COVID-19 was almost immediately panned almost universally as a politicized action by FDA. It did not help that the authorization was announced more like a campaign event than a regulatory milestone, with misleading statements, so much so that the FDA … Read more
FDA published a guidance this week about its on-site inspection policies during the pandemic which all but confirms that it is not planning to conduct any foreign on-site inspections and few, if any, domestic on-site inspections, till at least the rest of the year and possible into the first quarter of next year. FDA will … Read more
