iwewlkws In the last 5 years, the FDA has cleared about 120 software-enabled medical devices via the 510k pathway for various indications. A recent study of these discrepancies indicates that manufacturers of such devices might be exploiting a loophole in the current device regulation. A review of the 510k summaries and the subsequent marketing information of … Read more
Direct-to-Consumer (DTC) advertising must be truthful and non-misleading while presenting the risk and benefits of a given product in a balanced easily understandable format. Although there is extensive marketing research on the best ways to communicate drug related information to consumers, a new FDA guidance provides a review of the available information with recommendations for … Read more
Compounding pharmacies registered as “Outsourcing Facilities” are allowed to mass produce compounded drugs in anticipation of prescriptions but are not allowed to sell their products on a wholesale basis. This distinction between what compounding pharmacies are allowed to do and what they are prohibited from doing is described in a new guidance document from the … Read more
About a year ago, the National Kidney Foundation updated the formula for calculating the estimated Glomerular Filtration Rate (eGFR) by eliminating the race-criteria because it was found that the race-based algorithm incorporating GFR is delaying diagnosis and treatment of worsening chronic kidney disease (CKD). In a report published last week in the Journal of the … Read more
The annual report by the Office of Pharmaceutical Quality (OPQ) lists several updates regarding FDA’s CGMP inspection program along with several interesting factoids about the status of the drug supply chain in the US. The FDA has been developing a new inspection program for the last few years and the report summarizes what it has … Read more
Observational studies such as collection and evaluation of Real World Data (RWD) collected from medical records and other uncontrolled sources could play a crucial role in advancing medical knowledge by shedding light on disease incidence, prevalence, natural history, prognosis, and aiding in the development of clinical risk scores. However, when it comes to evaluating the … Read more
As longform artificial intelligence (AI) algorithms like ChatGPT become popular, these would obviously be used by authors to write, edit, or involve in other ways in the creation of manuscripts. To address the use of AI in scientific publication, the International Committee of Medical Journal Editors (ICMJE) revised the instructions to authors to not include … Read more
In its ongoing efforts to show how sponsors of market approval applications can provide alternate data to reduce non-clinical studies, FDA released a guidance describing Generally Accepted Scientific Knowledge (GASK) which can be used in lieu of animal studies. In the process, FDA also highlighted how subjective this assessment can be, and how it would … Read more
Decentralized or Virtual clinical trials have emerged as a game-changing approach to study the efficacy and safety of new treatments and interventions. But the regulatory expectations from these trial designs were not clarified. That is, till now. With two guidance documents released within the last month, the FDA has expressed its strong support for trial … Read more
Patients cannot read the fine print, called package insert (PI), accompanying their prescription drugs, leading to medication errors which in turn results in treatment failures and other serious consequences for the patients. To address that, FDA is proposing a new rule to require simplified drug information, called “Patient Medication Information (PMI)” for all prescription drugs … Read more
