Prahsant Kumar This week FDA published the final rule for the De Novo classification request for novel medical devices keeping the process mostly same as the previous rule. The process still requires that the applicant submit a detailed De Novo Class I or II designation request after the 510k application has been rejected or no predicate exists, … Read more
A new draft FDA guidance released this week describes all the factors that govern FDA’s decisions about market approval of new drugs and biologics, and it is apparent that the benefit-risk assessment of new products is far from black and white, but various shades of gray. The guidance appears more like an opinion article than … Read more
The 510k applications are one of the very few regulatory applications that are still submitted as fully or partially paper documents that must be mailed to the FDA offices rather than uploaded to the Electronic Submission Gateway (ESG). This week FDA released a guidance describing its process to transition to electronic 510k applications. The process … Read more
An old ethical question about should a sponsor pay or not pay subjects for participating in their clinical trials was investigated in two clinical trials, one with high risk to subjects and another with low risk to subjects. It was found that for the study where subjects would have low risk to participate, the financial … Read more
In almost 2 out of 5 cases where the efficacy data submitted in support of a market approval application was borderline (i.e., not clearly conclusive), FDA used its discretion to approve products, citing no clear public reasoning for its decision. Many times, it was done differently than FDA’s own previous decisions about similar applications. The … Read more
Biodistribution studies are needed for gene therapy products usually early on for better interpretation of the pharmacological and toxicological effects of the product, but these can be conducted under non-GLP conditions and use animal tissues specimens combined over multiple non-clinical studies. The new ICH guidance endorsed by the FDA this week provides several commonsense measures … Read more
FDA reversed its decision regarding the inadequacy of a small Phase 2 trial for the approval of a new drug for ALS under pressure from patient groups setting up yet another precedence for other similar developers of drugs for rare diseases with questionable data. Accepting this market approval application will set FDA to being forced … Read more
In an updated guidance document on developing new anti-microbial agents for use in food products, FDA listed the various common questions from developers of such agents with detailed answers to meet regulatory expectations. Emphasis is placed to defining the minimum level of an agent necessary to accomplish the intended action. Anti-microbial agents are considered food … Read more
You cannot claim your product is food while doing clinical trials that seem to make drug-like claims. An FDA Warning Letter to a microbiome company highlights the regulatory semantics regarding product designations and related regulatory obligations. Based on the endpoints selected for its clinical trials, Kaleido Biosciences Inc (KBI) was told by FDA that its … Read more
Since the beginning of the pandemic, many clinical trials switched from conventional monitoring to remote monitoring for obvious reasons. Now that the pandemic related restrictions are easing, there is no need to re-monitor sites which had been remotely monitored according to the FDA. Remote monitoring or centralized monitoring has been a permitted format for monitoring … Read more
