A GAO report on FDA’s foreign inspections paints a very dire picture for the current status of inspections. There are about 5000 manufacturing sites registered with FDA of which 3000 are located outside of the US; about 1000 of these foreign sites have never seen an FDA audit. With about 40% of finished products and … Read more
Data collected from doctors, medical records, insurance claims databases and patient registries regarding use of medical products and disease conditions, called “Real World Evidence”, is often claimed to be reliable, robust and credible enough to support regulatory decisions. The 21st Century Cures Act requires FDA to create a process to use Real World Evidence (RWE) … Read more
Like any other internet-connected device, medical devices can be hacked, and the hacked device used to harm the individual dependent on it. Imagine someone controlling the pacemaker embedded in your body or the infusion pump giving you life-support. It’s no different from someone pointing a gun to your head, with similar outcome. The possibility no … Read more
Contrary to popular belief, most of what FDA does is not influenced much by political changes. The Agency has exhibited remarkable bipartisan support for most of its mandates, and exceptional resilience for almost all its activities. FDA review processes, compliance verification processes, most project management activities, safety monitoring activities, and most regulatory decisions affecting the … Read more
Almost all clinical trial initiated after 18th January 2017 must be registered with clinicaltrials.gov. Last week, NIH released a short checklist with detailed explainer for sponsors to determine if their trials must be registered with clinicaltrials.gov. An excellent explainer answers several common questions from sponsors regarding registration. Several useful facts are clarified for example, a Phase 1/Phase 2 must … Read more
As much as 40% of food is thrown away every year by US consumers, retailers, restaurants, and other food operations, causing a loss of billions of dollars and negative environmental effects, according to USDA. An updated guidance from USDA explains the meaning of the various forms of food package dating and measures that must be taken before food is … Read more
Last year FDA released a Guidance Document regarding use of electronic informed consent in clinical trials. The use of electronic informed consent adds practical and logistical challenges to the informed consent process despite the obvious benefits. This week, FDA published additional guidance on a Q&A format seemingly to address the key concerns raised by users. The key process … Read more
The 505(b)(2) regulatory pathway is primarily designed to get FDA approval of new indications of previously approved products. A provision in the 21st Century Cures Act, that became the law this week, could create a promising expedited approval pathway for 505(b)(2) products. Developers of such products need to conduct randomized clinical trials (RCTs) for the new indication. The … Read more
This week FDA released a comprehensive list of all adverse events (AEs) reported to it related to food, dietary supplements and cosmetics for the last 12 years. This information was previously available only upon freedom of information request. The announcement “Why FDA Is Making Data Extracted from Reports of Adverse Events for Foods and Cosmetics … Read more
Regenerative therapies are set to receive renewed attention and attractive regulatory incentives thanks to the 21st Century Cures Act (Cures Act) which is all but certain to become the law this week. The new law defines “regenerative medicine therapy” to be cell therapy, therapeutic tissue engineering products, human cell and tissue products, and combination products using any such therapies or … Read more
