iwewlkws Ten years ago, the FDA published a guidance document about its opinion on what manufacturers should do when they become aware of independently generated off-label information about their approved products. This week, the FDA published an update to that guidance with similar info but with more examples and scenarios, which reemphasizes the voluntary nature of … Read more
FDA inspections are intimidating events. The audited parties could intentionally or unintentionally behave in ways that are deemed as delaying, denying, limiting or refusing inspection by the FDA inspectors which are all illegal activities with serious consequences. Most of these issue emnate from the mispercetions regarding the rights of the audited parties during such audits. … Read more
If you think that the FDA is a “Black Box” where critical decisions are made in a subjective and opaque manner by a few powerful executives, you are not alone. Last week’s decision by the Director of the Center for Biologics at the FDA, Dr. Peter Marks, to expand the approval of Sarepta’s treatment for … Read more
The FDA has created new rules specifically for medical gases to improve how they are labeled, manufactured, certified, and reported for safety. These rules aim to address the unique characteristics of medical gases and ensure that they meet safety and quality standards. Under the new rules, manufacturers of medical gases will be required to follow … Read more
The FDA has set rules under the GDUFA III commitment for how to handle a facility’s readiness for inspection for ANDA applications, which affects the goal date for an application. A new FDA Guidance Document released this week provides a simpler breakdown of these rules. Applicants must list their manufacturing sites and their contact info … Read more
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
