Prahsant Kumar The ICH E6 guidance document and FDA’s clinical trial guidance contain requirements for good clinical trials, but they do not address practical issues related to the conduct of clinical trials particularly in resource-limited and multi-national settings. All locations where trials are being conducted or planned to be conducted are not the same in terms of … Read more
Some manufacturing changes could affect the biological properties of human cellular and tissue-based products (HCTPs) to an extent that may require a new IND or a BLA supplement. Unlike drug products, HCTPs are manufactured with limited information on several key aspects of process and product characterization lending them to higher risk when changes are made. … Read more
Since its inception about 5 years ago, FDA’s Breakthrough Device Program has been involved in 67 new device approvals out of about 700 devices designated as breakthrough devices. A review of the devices designated as breakthrough and approved via this pathway indicates a few interesting trends for this program such the indications for which FDA’s … Read more
Priority review vouchers (PRVs) are a less discussed incentive from the US government to developers of new drugs for certain diseases. These are hard to get but provide an immediate financial gain to the company securing it. So, can developers design programs aimed specifically at benefiting from them? In the last 14 years, there have … Read more
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
