Prahsant Kumar 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
The FDA has more than 18,000 full time employees and an annual budget of over $6 billion. It is high organized, and its regulators are considered some of the smartest in the World. It can handle challenges, or so it would appear to the lay person. Last year, FDA delayed many of its review activities … Read more
A review published in the British Medical Journal this week reported that almost 44% of drugs approved by the FDA under the accelerated approval pathway over the last 28 years have not yet been confirmed to be clinically effective, and despite that most of these unconfirmed drugs are on the US market for 5 years … Read more
Yesterday’s approval of the first interchangeable biosimilar by the FDA provides a proof of concept for biosimilars that will be treated like generic drugs in that they can be substituted for the reference product at the pharmacy without needing a specific prescription. This is a major milestone that has been almost 10 years in the … Read more
