iwewlkws FDA inspection or audit for Good Clinical Practices (GCP) is an important step for the FDA review of market approval applications. Although GCP audits have been conducted for more than 50 years, there has been little formal guidance from the FDA about the processes involved, leading to several anecdotes and perspectives. A new FDA guidance … Read more
This week, the FDA announced six initiatives to address various aspects of medical devices based on artificial intelligence (AI) and machine learning (ML). The programs will address major issues that should be discussed with the FDA when developing and using AI/ML technologies in medical devices. The first initiative discusses the limitations of medical data in … Read more
Diversity of the participants in clinical trials has been a hot topic of discussion for the last decade fueled by the anemic data from such populations in market approval applications. So far, most of the focus has been on industry-funded trials but how do government-funded trials fare in their ability to recruit diverse populations? A … Read more
While the gold standard for pre-approval clinical trials is the randomized clinical trials (RCTs) design, post-market studies should follow the pragmatic clinical trial (PCT) design for better information about the drugs in the real world setting. FDA’s top management published a perspective this week that asserts that this would help better understand how well the … Read more
This week the FDA released its “Platform Technology Designation Program” to formally recognize well-understood and reproducible technologies in FDA-approved drugs or biologics that could be used for future product development and approvals. It is important to understand the difference between this and the cross-referencing process used commonly to leverage previously submitted information for new applications. … Read more
As expected and promised, the FDA got sued this week for the new LDT Rule. In its latest attempt to regulate Lab Developed Tests (LDT), the FDA designated all such tests as conventional in vitro diagnostic (IVD) tests that require registration and formal approval or clearance by the FDA as a medical device. The lawsuit … Read more
Direct-to-consumer (DTC) advertisements for prescription drugs and biologics are important for creating product awareness among potential users/patients in the US and critical for their commercial success. Starting this week, a new rule for the tone and content of these advertisements has come into effect that requires these ads to meet five standards to ensure that … Read more
The scientists at the National Institutes of Health (NIH) US, the world’s largest government-funded research center, invent hundreds of new patented medical technologies each year that are licensed to industry partners for commercial development. NIH is proposing a change in its licensing terms to include additional commitments from the licensees for post-approval commercial activity for … Read more
Over the last year, numerous researchers have evaluated the potential of ChatGPT in healthcare applications from writing medical notes, to diagnostic decisions, prescription recommendations, and even medical consultations and research. However, ChatGPT is but one of the various large language models (LLMs) being evaluated in healthcare. And they all are in their infancy. ChatGPT has … Read more
Over the last decade, the FDA has repeatedly expressed strong interest in real world evidence (RWE) from real world data (RWD) in support of regulatory decisions but very few market approval applications significantly depended on RWE over the same period as shown in an independent review. It is critical to understand the reason for this … Read more
