iwewlkws As the new LDT rules get reviewed by the courts, a new study points to another concern with LDTs; the extreme social media promotion of these tests. Are these tests improperly promoted on social media leading to their overuse and overdiagnosis? How do those concerns play into the regulatory concerns raised by the FDA in … Read more
What if the people involved in the review of your application at the FDA got fired? It is not an anecdote but the reality that hit several companies last week. What is expected from the sponsors working with those individuals who are no longer employed by the FDA? It’s a tough question. There are some … Read more
The kind of cuts in its workforce and major policy changes that the FDA has seen in the last month, it did not see in its entire 100-plus-year history. This, in turn, has exposed what the FDA was always accused of; being a strongly politically-influenced organization that is not as independent as it claims. But … Read more
A recent Warning Letter for conducting clinical trials with a supplement without FDA approval highlights the fine line that separates trials that need the FDA’s pre-approval to initiate and those that don’t. The FDA inspectors dinged a company in California for conducting multiple clinical trials with their probiotics because of certain endpoints selected for those … Read more
Conducting clinical trials for heart-related diseases in the U.S. is difficult, even though these diseases affect many people. To gather enough participants, trials often need large networks of locations both in the U.S. and internationally. If a study does not enroll enough people, it can face delays, waste resources, and take longer to complete. Because … Read more
Institutional Review Boards (IRBs) are required to create and follow written Standard Operating Procedures (SOPs) under US regulations. Each IRB created SOPs it deemed necessary to bring it into compliance with the lab. But is that enough for the FDA? Apparently, there were concerns about the adequacy of SOPs at the IRBs as the FDA … Read more
The true cost of developing new drugs has been debated for the last 40 years. A broadly accepted number for developing a new drug is $1-2 Billion and 10+ years. But does it really cost so much? Similar things have been said about the cost of developing Artificial Intelligence (AI)-chatbots like ChatGPT until DeepSeek showed … Read more
Years after the height of the COVID-19 pandemic, millions of individuals continue to suffer from Long Covid—an often debilitating condition with symptoms ranging from chronic fatigue and brain fog to cardiovascular and respiratory issues. Despite the pressing need, there is still no definitive treatment for Long Covid. Understanding the reasons behind this delay requires examining … Read more
Many pundits worried that last week’s rapid purge of information about diversity and inclusion in clinical trials for cancer drugs on the FDA website signaled that the FDA no longer requires diversity in clinical trial participants. It may not be that simple. The need for diversity of clinical trial participants is not a political issue, … Read more
Investigating and addressing deviations in the manufacturing process is a critical requirement for compliance with Good Manufacturing Practices (GMP). A Warning Letter (WL) issued to Sanofi’s drug manufacturing facility in Paris highlights the procedural deficiencies that all manufacturing facilities should address to stay GMP compliant. Deviations from the process could happen for various reasons. … Read more
