iwewlkws 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
Many clinical trials involve collecting tissues from trial participants as a part of the clinical protocol which inherently adds varying degrees of risk to the participants. The FDA has specified conditions under which biopsies could be collected and the processes involved to adequately control the amount, type, and quality of the tissue sample collected in … Read more
A few controversial approvals in the last decade have clouded the public perception of the Accelerated Approval (AA) pathway. The Congress last year gave the FDA an additional mandate to enforce timely completion of the post-market clinical trial commitments thereby increasing the burden of maintaining the approval on the sponsors. The AA pathway’s credibility relies … Read more
The U.S. Food and Drug Administration (FDA) approved 50 new drugs last year, which is at par with the average of about 50 new drug approvals each year that the FDA has maintained over the last decade. There are some trends that have continued this year and could help developers strategize for the years to … Read more
The FDA’s new year gift to the industry is a record-breaking reading assignment; it released 31 Guidance documents on the first Monday and Tuesday of the year. In an unprecedented data dump of sorts, the guidance documents span all centers at the Agency. This is not normal by any standards but how does it impact … Read more
The U.S. Food and Drug Administration (FDA) recently updated its guidance titled “Registration and Listing of Cosmetic Product Facilities and Products.” This document aims to help cosmetic businesses understand the requirements for registering their facilities and listing their products with the FDA. The updated guidance includes finalized frequently asked questions (FAQ) in Appendix B, specifically … Read more
