Does Your IRB Have These 55 SOPs? FDA Gives a List

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

What Does DeepSeek Teach the Pharma Developers?

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