A recent publication of a placebo-controlled clinical trial in China with a Traditional Chinese Medicine (TCM) product showed signification benefits in the management of Acute ST-segment elevation myocardial infarction (STEMI). However, what would be the likelihood of FDA acceptance of clinical data from such a study to support its approval as a conventional drug? 0 … Read more
With a wide-ranging and far-reaching Executive Order signed this week by President Biden, the administration is implementing several requirements from developers of products containing Artificial Intelligence (AI) technologies that would affect digital health products, somewhat. The order is primarily focused on the safety and privacy of the information used to train AI algorithms but also … Read more
Often patients request transfusion of blood donated exclusively from specific individuals, like relatives, friends, or those with specific characteristics (e.g., gender, sexual orientation, vaccination status, or religion). Recently, there has been a surge in directed blood donations where patients wanted blood transfusions from donors who did not receive COVID-19 vaccinations. The FDA, the American Blood … Read more
FDA’s enforcement policy for the distribution of off-label or unapproved information by manufacturers has come a long way in the last decade; from very conservative to reasonably flexible where companies can share off-label information freely provided they follow some basic rules prohibiting overt promotion using such information. This week’s new FDA guidance adds to the … Read more
Last week, the FDA directed a South Korean drug manufacturer to hire a consultant to help with numerous non-compliance observations during an audit of their manufacturing facilities in South Korea. Such “suggestions” to audited parties to hire external experts are occasionally made in Warning Letters. But are the manufacturers obliged to follow through? FDA audits … Read more
Earlier this month, the FDA issued a Warning Letter to an online pharmacy selling a generic version of GLP-1 analog, semaglutide, and in the process highlighted the limitations of such FDA actions for online pharmacies selling illegal products. So long as the consumers are willing to risk buying products online from dubious companies, the FDA … Read more
Earlier this year, Pfizer suddenly dropped 3500 patients participating in a clinical trial to evaluate its vaccine for Lyme disease citing violation of Good Clinical Practices (GCP) at its CRO vendor. This week, the CRO announced that it was audited by FDA inspectors who found no violations. So, did Pfizer make the wrong decision to … Read more
Animal studies are critical for demonstrating the safety of a product prior to the initiation of human clinical trials. Clinical trials will not be allowed to proceed by the FDA if any major product-related safety issues are observed in animal studies. But did Elon Musk’s company get a break from this policy or lie to … Read more
Starting October 1, 2023, FDA no longer accepts paper 510k submissions. As announced before, 510k applications must be created using the eSTAR template and submitted electronically to the FDA for review. This week FDA released the final guidance for the electronic submission of 510k applications, confirming what it proposed about a year ago. Some important … Read more
For the last 15 years, the FDA’s attempts to regulate Lab Developed diagnostic Tests (LDTs) were rebuffed due to the lack of political will for such regulation or public support. FDA unsuccessfully tried to get Congress to pass new LDT laws, and its proposed guidance documents to regulate LDTs were derailed by strong opposition from … Read more
