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
Clinical trials for oncology products have come to literal standstill due to the pandemic and it seems it would be at least 2-5 years before things go back to pre-pandemic levels. Not only that, the pandemic has also severely curtailed the fund-raising for companies and non-profit organizations in the oncology space, some by as much … Read more
Placebo-controlled studies are the global gold standard to evaluate the safety and effectiveness of new drugs. However, can placebo make a new product look better than it actually is by causing adverse effects not otherwise seen or inducing other artifacts that make the active drug look better? An interesting commentary in the Journal of American … Read more
