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
Starting this Monday, 30 August 2021, submitters of traditional 510(k) applications can directly track the progress of the review of their applications on FDA’s website via an online web-based tracker. This should allow applicants to plan their subsequent steps in marketing their product under review. The most common complaint from submitters of any application to … Read more
Since the approval of the Alzheimer’s Drug, Adulhelm, almost three months ago, the accelerated approval pathway (AAP) has been criticized, to a large extent, unfairly. The criticism misses the lax enforcement of the well-established rules for the pathway by the FDA for such decisions. The AAP requires demonstration of benefits of a new drug in … Read more
Doctors often prescribe FDA-approved drugs to patients who may not be eligible for them based on the labelled claims for the drug, on a case-by-case basis. Such off-label treatment is an important part of patient care in the absence of a specific approved treatment. Now that the Pfizer’s COVID vaccine has been approved, concerned parents … Read more
FDA recently rejected a petition to classify CBD as a dietary ingredient saying that since it has already approved a drug containing CBD, all CBD products are drugs and cannot be classified as dietary supplements. There are many reasons this argument from FDA is hollow and baffling. While on the record FDA has consistently argued … Read more
Two-thirds of the sponsors of clinical trials intend to continue remote clinical trials post-pandemic. Trials that are entirely run using electronic documentation, digital communications, and remote monitoring cost more than conventional studies due to the initial investment in technology acquisition, but the increased cost was off-set last year by reduced travel and conference costs, and … Read more
Despite more than half of the population fully vaccinated in the US, it is ironic that the vaccine misinformation has barely waned. A wide swath of population still believes scientifically implausible myths about the vaccines. It may seem disturbing that a large section of the population believes that Covid vaccines can cause infertility, or that … Read more
A report on a systematic analysis of the real world studies conducted with FDA-approved cancer drugs found that almost all such studies were of poor quality and hence led to erroneous conclusions. The list of challenges noted in the report are likely applicable to most real world data collected by researchers to either support conclusion … Read more
