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
In a stinging rebuke of their policy to withhold critical information about Plavix from FDA and the public, a judge in Hawaii fined BMS and Sanofi $834 million. Although the judge found the companies guilty of deceptive marketing, the ruling document describes a detailed timeline of information available to the company which could signal additional … Read more
Only 16% of the times when a company gets a Refuse to File (RTF) notification, it tells the public about it, and even then, only 5% of the times, the company accurately discloses the reasons for the refusal, FDA reports. Companies obviously want to control the negative information about their applications and FDA want to … Read more
Last week after FDA persuaded its oncology drug advisory committee to soundly reject a new drug approval application due to it being based on clinical data exclusively from China, some may have been given the impression that FDA no longer accepts clinical data from China for market approval in the US. It is far from … Read more
The FDA would soon have a new commissioner and among several leading contenders for the position is the 37-year veteran of FDA, Dr. Janet Woodcock. Like others, we speculate if this is the year, she finally becomes the FDA commissioner. This has been a good year for experienced people who outperformed others in highly competitive … Read more
