Prahsant Kumar The year 2022 was the year when the pandemic came to an end, unofficially at least, but there are many things at FDA that started with the pandemic and changed it for good. While these changes may not affect the core rules, they affect the relationship between the FDA and all the stakeholders in significant … Read more
It should be a moot point that clinical trials cannot be conducted without filing an IND application with the FDA and waiting for the FDA clearance prior to initiating the trial in patients. It also should be a moot point that IRB approval alone is not sufficient to initiate clinical trials with drugs and biologics. … Read more
The regulation of medical software by FDA, whether it is used standalone or as a component of another device, is rife with confusion. FDA released an online tool this week that attempts to answer the most common questions from software-as-a-medical device (SaMD) developers. SaMD products come in several forms. These could be simple health related … Read more
An external panel of experts tasked with reviewing FDA’s current practices for regulation of food supply chain recommended a proactive approach to supply chain regulation and restructuring FDA’s organization to create clearer leadership at FDA for food regulation. These organizational changes, if implemented, will streamline FDA’s oversight of food supply chain without necessarily creating new … Read more
A survey of publications for cancer clinical research in major journals found that in about 20% of the papers, the authors promised public availability of the data related to their research and only about 1% provided data that met accepted standards for completeness and transparency. Most journals require data sharing commitment as a condition for … Read more
In 2016, CDC published a list of recommendations for physicians prescribing opioid pain medications, to assist in judicious and diligent prescription of these critically needed drugs with high abuse potential. Five years later, CDC now believes that these “voluntary” recommendations may have hurt patient care by creating overtly restrictive opioid prescription policies, non-intended by the … Read more
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
