In recent years, FDA has increasingly observed CGMP violations involving data integrity during CGMP inspections. This is troubling because ensuring data integrity is an important component of…
While the FDA has been actively enforcing data integrity since the early 2000s, it has been late to the game publishing guidance on this topic.…
The growth of the pharmaceutical industry and its willingness to explore novel strategies in drug development and delivery is reshaping the industry and renewing interest…
Elissa Epel, PhD, a professor of psychology who co-directs the UCSF Aging, Metabolism, and Emotions Center, believes one’s chronological age and biological age do not always…
Walk into any grocery store, grab a few packaged products, and flip to the ingredients. You’ll likely spot added sugars – lots of them –…
Using a common type of brain scan, researchers programmed a machine-learning algorithm to diagnose early-stage Alzheimer’s disease about six years before a clinical diagnosis is…
The billions of bacteria that call your gut home may help regulate everything from your ability to digest food to how your immune system functions. But scientists know…
My hope is that you are on a couch or in a comfy chair sipping hot chocolate or some other holiday beverage as you read…
Without management commitment to safety, a company cannot achieve best-in-class results. Have you ever asked the question, “What else can I do to improve our…
Senior quality leaders and the FDA agree quality organizations supporting pharma manufacturing often fall short of providing the support necessary to maintain and increase regulatory…