Resources

The FDA had sent one of their best and toughest inspectors. The facility was located in Costa Rica. I had been sent there from the US to help a sister company with a pending inspection. I had arranged a dinner the night before the start of the inspection at a (supposedly) nearby restaurant in order […]

FDA’s touches the lives of every American at least 6 to 10 times each day. The agency oversees 80% of the nation’s food supply, all of animal/human medical cosmetics and products, and almost all radiation-emitting devices. Put all that together, the agency is responsible for about 20% of all consumer dollars spent in the United […]

New heads of Quality Assurance come into pharmaceutical companies all the time for various reasons. If you are the new head honcho of quality, hopefully you were able to get some sense for the reasons for the vacancy during the interview process. I recognize that this is not always easy in an interview situation. I […]

When when I read the posts from this week’s grand rounds, I am astounded at how advanced, how intense, how personal, how vast, and also how amazingly complicated health care here in America is.  It’s so complicated that probably only the most astute health care observers and healthcare management degree students will even understand every […]

I am often asked how best to prepare for an FDA inspection when you already know that you have problems. My first response is that they have already taken the first step: acknowledging that there are problems. Believe me. That is a huge first step. Just like AA’s 12 step program, it’s not until you […]

We’re happy to announce that FDAzilla will be hosting Grand Rounds next Tuesday, January 11. What is Grand Rounds? It is a weekly round-up of the best medical and healthcare blogging. The theme of the week is anything to do (even tangentially) with medical devices and/or pharmaceuticals. Nonetheless, we’ll likely work in most (if not […]

We live in a news-driven world, and sometimes it’s like drinking out of a firehose. So, to save time, here were some of the key developments related to the FDA over the last month. FDA vs. no FDA. Commissioner Hamburg wrote an elaborate piece on Innovation, Regulation, and the FDA, essentially justifying the existence of the […]

Hello from snowy Chicago!  This is Tony Chen from FDAzilla with a quick update. FDA information is often hard to use – to the point of just not using it.  We believe there’s a better way.  So our redesigned website includes free, fully-searchable FDA data, including the FDA employee directory, drugs, device actions, 510Ks, MAUDE, […]

The Warning Letter to Claris Lifesciences was one that went on and on, page after page citing violations of fundamental, block-and-tackling practices. This was surprising and a disappointment given that Claris is one of the largest sterile injectable pharmaceutical companies in India with a market presence in 76 countries worldwide.  From a patient’s perspective, their […]

Anyone not know the name of Julian Assange, founder of Wikileaks? Under the guise of “transparency” and “revealing suppressed and censored injustices”, Assange has opened up hundreds of thousands of documents, some of which, the Pentagon claims, have provided dangerous info to enemies of the U.S. “damaged operations”.  I’ll leave the debate on Assange’s motives to […]