Prahsant Kumar The FDA released a user guide, the Learning and Education to Advance and Empower Rare Disease Drug Developers (LEADER 3D) based on case studies highlighting key concepts and regulatory considerations crucial for successful rare disease drug development programs. The case studies present successful approaches used by sponsors in designing and conducting their rare disease drug … Read more
Pharmaceutical companies are often seen exploiting legal loopholes to increase their profits at the expense of patient safety. The case involving Gilead Sciences highlights a troubling delay in releasing a safer drug, raising important questions about the impact of corporate decisions on public health. Of particular concern is a tactic known as “product hopping” which … Read more
Artificial intelligence is transforming healthcare, but is it ready to replace human touch? As technology advances, a new study investigates the effectiveness of AI, specifically ChatGPT, in answering patient questions compared to experienced surgeons, revealing surprising insights about communication in medicine. Bots like ChatGPT are designed to understand and generate human language. ChatGPT can interpret … Read more
Human cells and tissues must be vigorously tested for contamination from infectious pathogens. Seems like a common sense approach to easily avoid spread of infectious diseases. But not every collection, processing, and storage site for human tissue follows this simple screening step for their operations. A Sperm Bank in California got a Warning Letter for … Read more
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
