Pearls of Wisdom
What the Historic FDA and EMA Mutual Recognition Agreement Means for Drug Companies
Fear. Anxiety. Sleepless nights. Terror of noncompliance. Remember those thoughts that raced through your mind when you heard a regulatory agency was going to inspect your facility? And then, multiply that by ten when you learned that not only members from...
The Novartis Data Scandal Explained
On August 6, 2019, the U.S. Food and Drug Administration (FDA) released a statement that Novartis AG withheld notifying FDA about falsified data found in preclinical animal studies until after their $2.1 million gene-therapy drug, Zolgensma, was approved....
Acting with integrity within the sometimes-unethical pharmaceutical industry
Book: Bottle of Lies: The Inside Story of the Generic Drug Boom, by Katherine EbanGood read.I honestly forgot about the phone call I had with Katherine Eban more than 5 years ago, so it took me by surprise to see my name in her book. Yes, right there on...
Enhancing the diversity of clinical trial populations – FDA releases draft guidance for industry
Clinical trials are due for a big change up as the US Food and Drug Administration (FDA) looks to alter a major part of the testing process. In June 2019, FDA created a draft guidance with the goal of diversifying clinical trial populations. In the...
What to Do During Those “Oh No” Moments: Questions from Regulators
We have all experienced them: those moments when all you can say is, “Oh, No!” or perhaps, “Oh $%&@!” Such moments happen in the development lifecycle of a drug or device all too often. What you do and say next can have huge impact on your product. So,...