iwewlkws It is not widely known that FDA publishes on its website a list of qualified tools that developers of medical devices can use to generate supporting information for their market approval applications. These tools have been vetted by FDA as “well-defined and reliable measure of a specific concept” and hence interpretations of benefits based on … Read more
At the height of the Covid pandemic, Indian regulators cut corners to expedite an indigenous vaccine, Covaxin. While the process followed may be questioned, in all fairness, this decision saved the lives of tens of millions of Indians. It does not reflect on the entire Indian regulatory process, and it does not mean that every … Read more
To prepare healthcare delivery organizations (HODs) plan, prevent and address cybersecurity issues, FDA released an updated playbook listing expected processes and tools at these organizations. The playbook lists various scenarios that may be encountered when using connected devices containing sensitive medical information, steps to reduce their vulnerabilities to malicious attacks, and addressing the incidents when … Read more
A joint report of the review of internal processes at the FDA for the Breakthrough Therapy Designation (BTD), and at the European Medicines Agency (EMA) for its breakthrough drug program called the Priority Medicines (PRIME), shows that the two agencies when presented with the same data for a product, interpreted in an opposite manner about … Read more
An antiquated FDA policy prohibits collection of tissues, cells, organs, and blood from gay donors and sub-Saharan African immigrants. These prohibitions apply even if vigorous testing shows these donors to be non-infectious and healthy. These prohibitions are enforced by the FDA through improper means via its Guidance Documents and not through the appropriate regulatory process. … Read more
More than 250 million people visit their local Walmart every week. Is it possible for Walmart to use its access to people as a resource to recruit patients in clinical trials? We will find out soon. Last month Walmart announced that the Walmart Healthcare Research Institute will help recruit patients for clinical trials in chronic … Read more
There are two ways patients can get access to experimental drugs outside of participating in a clinical trial: The Right-To-Try (RTT) access or the Expanded Access. FDA prefers patients to use the expanded access program over RTT since that way FDA can better monitor the non-clinical trial use of experimental treatments. FDA’s latest guidance on … Read more
A key application of digital medical tools is in diagnostic applications that rely on artificial intelligence (AI) algorithms. Experts opine that there are critical deficiencies in the methods used for training and validation of AI tools that might over-estimate the accuracy of these products, and hence make them less reliable. These deficiencies must be addressed … Read more
A new drug can affect multiple aspects of the disease it is intended to treat, and hence clinical trials are designed to evaluate multiple efficacy endpoints compared to the controls. However, evaluating multiple endpoints in a clinical trial should involve appropriate statistical adjustments to account for the existence of multiple comparisons, called the multiplicity effect. … Read more
Today FDA announced a new program for advancing Real World Evidence (RWE) aimed to develop new approaches for using RWE for labeling changes, new indications for previously approved drugs, or to support post-market commitments. The program will select a few sponsors who want to use RWE for the above purposes and use the experience and … Read more
