iwewlkws The primary concerns with the safe and effective use of AI-enabled medical devices are their trustworthiness, fairness, and performance. The FDA proposes a lifecycle management (LCM) approach to better address these concerns. This week, a series of blog posts by the FDA’s office leading review of software medical devices (SaMDs) describes an AI life cycle … Read more
Since August 2017, the FDA has released 11 guidance documents describing various aspects of real world data (RWD) and real world evidence (RWE) in regulatory decision-making. The 12th guidance document released this week describes expectations from clinical studies that use RWD sources, Electronic Health Records (EHRs), and medical claims data, to derive RWE. This guidance, … Read more
There are more than 20 FDA guidance documents on various types of FDA meetings with the sponsors which can be confusing because similar information is repeated across multiple documents. On the other hand, the FDA’s internal processes for managing meeting requests highlight a unified FDA approach to different meetings. How does the FDA staff process … Read more
Post-market pharmacovigilance could be improved to collect robust data from the use of products to generate data acceptable to regulatory agencies for new claims for the safety of the products. A new ICH guidance describes various parameters to plan for which would create such robust data. Post-market use is “free” data that could help companies … Read more
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
