We often hear the manufacturer’s side of the FDA audit experience but not what happens internally at the FDA. A recently concluded investigation of a disagreement between an FDA inspector and his manager regarding his reports of non-compliance at manufacturing facilities by the Office of the Special Counsel provides a unique insight into FDA’s internal … Read more
Complaints by whistleblowers do not lead to automatic investigations by FDA and could take years for FDA to find credence. Many a times we know about whistleblower complaints to FDA that seemingly do not go anywhere as the alleged violators continue without any FDA investigations or negative consequences. There is no simple answers as to … Read more
Did the notification process, used as a precursor to filing an EUA for Covid diagnostic tests, help or hurt both the consumers and developers? A review of last years’ experience with the notification process for the EUA showed that FDA’s plan was poorly thought, knee-jerk reaction in the early days of the pandemic, and ended … Read more
In an atypical move, many medical device companies are petitioning FDA to continue the 510k requirements for several Class II devices after FDA proposed that those devices are safe enough to not need such regulation and should be downgraded to 510k-exempt status. And in the process, the commenters exposed many holes in the current regulatory … Read more
Last year between March and December, FDA “reduced the need” for Pre-Approval Inspections (PAI) by more than 50%, and still met almost all its product approval timelines (93-100% of the times), raising the question if these inspections can be reduced for good. The year of the pandemic forced FDA to do an experiment otherwise impossible; … Read more
One year after the pandemic, there is still a critical shortage of laboratory supplies affecting most research activities indirectly. A survey of testing labs by the American Society for Microbiology in January found that supply shortages were affecting almost 50% routine bacterial testing, 35% sexually transmitted diseases, 30% mycobacteria, and almost 20% routine fungal tests. … Read more
It is ironic that on the first anniversary of the pandemic, we are worrying about how to deal with an excess of the vaccines. It may seem too early to discuss this, but it is not. While it is certainly good news that we will have sufficient vaccine to cover almost everyone in the world … Read more
Emergency Use Authorizations (EUAs) became a household term last year due to the Covid pandemic. Every single product to prevent, diagnose or treat the infection was cleared via the EUA pathway. But as the pandemic comes to an end, the Emergency Declaration that allowed the EUAs to exist will be terminated, making all the EUA … Read more
FDA released a strange email “request” today to firms issuing misleading “FDA Registration Certificates” that look like government documents and include FDA’s logo. FDA is aware that such certificates, which are very common for Class I medical devices, are used to deceive consumers to think a device is approved by FDA based on an establishment’s … Read more
In the last 12 months, more than two thousand Phase 2 and 3 clinical trials were launched worldwide to evaluate various therapeutics for COVID-19, containing 2895 individual treatment arms aiming to recruit more than 500,000 patients. However, an FDA analysis showed that only 5% of these trials were randomized and adequately powered, accounting for about … Read more
