Tag Archives: FDA

Who can see Form FDA 483s, and where do I get them?

Previously, we talked a bit about what the big deal is about these Form FDA 483s.  Today, we talk about how to get a hold of actual 483 reports and who else can see them.  This is where things get a little more tricky.  Theoretically, Form FDA 483s are public information and, thus, available through the FDA’s Freedom of Information Act Office.  So, any Form FDA 483 can be requested by anyone. Continue reading

Company Culture and CGMP Compliance

I’ve come to the conclusion that compliance with the FDA Current Good Manufacturing Practices (CGMP) is just as much about company culture as it is about anything else. A corollary to this is that resolution of regulatory compliance problems is just as much about organization transformation than anything else. Continue reading

Top 31 Websites (and Tweeters) on the FDA

If any part of your life includes trying to figure out how to work smarter with the FDA, this is for you.  Here’s our list of the top 40 31 online destinations on the FDA and some of the key industries it regulates.   We applied only one criteria to make it on this list:  free, up-to-date, and valuable content. Continue reading

Tales from the Front: With the FDA in Costa Rica

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 for the FDA inspector and his wife (did I mention he brought his wife with him?) to meet the President of the Costa Rica company. With any luck, it would help the upcoming inspection go smoothly. Continue reading

State of the FDA

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 States.

With the President set to deliver his State of the Union address to Congress in a few days, it seems a good time for FDA Matters to provide its view of the “State of the FDA.” At the beginning of 2011, the agency is doing well, but has a lot of catching-up to do and faces a number of threats. Continue reading

Grand Rounds 1.11.11 | It’s Complicated

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 post below.

As you read through the best posts from the medical blogosphere for the week, just think about how amazing all of this is –  health care leads to all kinds of misconceptions, frustrations, discoveries, inspiration, opportunities, tragedy, and humor. Continue reading

FDA Inspections: Being prepared when you know you have problems

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 are willing to admit this aloud that you are on the road to recovery. But just knowing that problems exist is not enough to survive an FDA inspection.

Here are the various positions that firms find themselves when the FDA comes knocking. You can decide which of these scenarios is the best possible position. Continue reading

Dec 2010 FDA Round-up: 5 Trending Topics

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.

  1. FDA vs. no FDA. Commissioner Hamburg wrote an elaborate piece on Innovation, Regulation, and the FDA, essentially justifying the existence of the FDA.  Well-written and rich in lessons from history.  For better or worse, the FDA usually gets a big boost in funding and responsibilities every time there is a big health outbreak or crisis.  Only then is it politically tenable.  And only then do we not take for granted the safety of the products we put in our bodies.  Speaking of which, the Food Safety Modernization Act was passed, or was it?  Odds are it will be passed in the next week. Continue reading

Analysis of the Claris Warning Letter

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 products are injected directly into the human body and are used in the treatment of critical illnesses.

So extensive is the Warning Letter that it is organized into sections that conveniently walk the reader through the logic of the inspection: CGMP Violations (that cover the gamut), Field Alert Reporting Violations, Unapproved New Drug Violations, Adverse Drug Experience Reports, and a Conclusion. Continue reading

WikiLeaks, Transparency, and the FDA

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 others; here I want to discuss  transparency and the FDA.

Transparency is a word that has lost its meaning with overuse.   Especially with the advent of social media, we now have unparalleled access to learn more about our friends, favorite celebrities, and even corporate entities. Continue reading

FDA Enforcement Inflation: What’s Next?

I grew up in a home where just a cast of my mother’s glance was enough to cause me to stop dead in my tracks. I knew “the look” quite well.  There were no raised voices.  When a parent doesn’t follow through on the gentlest of correction, then the parent is communicating that an appropriate response is optional. Out of frustration, parents often up the ante by resorting to yelling and making idle threats. Nothing really changes, because nothing has to. There is more yelling than consequences.

Such has been the history of FDA regulatory enforcement. The threats had to escalate. Their voice had to get louder. The stakes had to get bigger to get industry attention. Continue reading

FDA’s Only Getting Tougher

It’s been quite a year or two at the FDA since Commissioner Hamburg took over.  Of particular interest to me is their increasingly tough stance on inspections and marketing issues.  Here are some highlights:

  • The FDA wants to prosecute pharma and device execs should their firms engage in off-label marketing.  With what is known as the Park Doctrine, execs could face up to a year in jail + $100,000 fines.  This would be on top of the billion-dollar+ fines the companies have paid (which have not dissuaded them from trying to get away with things). Continue reading

Who works at the FDA?

If you’ve ever tried to contact someone at the FDA, you likely went to the HHS employee directory.  We’ve decided to make that directory even easier to use by making it searchable by title, name, phone number, and even location.  Check out our FDA employee directory here.

Some interesting tidbits I’ve noticed from doing a few searches.  The FDA employs: Continue reading