iwewlkws 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
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
