Responding to 483s and Warning Letters:
Strategies for High-Stakes Communications
Fact:
When the FDA issues a 483, how you respond can make all the difference in the world. The stakes are tremendously high — from increased frequency and intensity of inspections to severe punishments such as recalls, seizures, denial of access to the market, fines and criminal prosecutions.
Yet companies continually respond in an unsatisfactory manner. More than half the warning letters issued in January 2007 acknowledge that a response to the 483 was received, but the response was "incomplete" or "inadequate."
How can you be certain your response will satisfy the FDA?
In this one-of-a-kind, 90-minute audio CD/transcript, noted attorneys Fredrick H. Branding and Cathy L. Burgess will present best practices and lessons learned from decades of representing drug, device and biologics manufacturers. They will demonstrate how to analyze the FDA's concerns, respond in an appropriate fashion and avoid making common mistakes that result in inadequate responses. They will examine language from actual 483 and warning letter responses and explain why the response given was good or unsatisfactory.
These experts will thoroughly examine:
- How to analyze a 483 or warning letter — what the inspector is looking for is not always obvious
- A checklist of 10 dos and don'ts for responses — have these close at hand before you write your response
- The proper structure of a response — the FDA is less likely to miss the good things you're doing if you provide the format they want to see
- Five common mistakes to avoid — now is not the time to wave a red flag
- Making and keeping FDA commitments — showing good faith can go a long way
- Developing timelines for corrective action plans — it's not just what you do, but when you do it
- The importance of supporting documentation — if you can't prove it, you didn't do it
Don't risk losing millions of dollars. Be confident in your response the next time your company receives a 483. Order now. You'll get an opportunity to hear your colleague's toughest questions during the Q&A session.
Fred is a former chief of the Civil Division of the U.S. Attorney's Office for the Northern District of Illinois and chief of the Psychotropic Drugs Unit of the U.N. International Narcotics Control Board in Vienna, Austria. While at the Department of Justice, he twice received the FDA Commissioner's Special Citation for outstanding contributions in the field of food and drug law enforcement. He is an adjunct professor of food, drug and cosmetic law at Northwestern University School of Law. Fred earned his pharmacy and biology degrees from Drake University and his J.D. from the Illinois Institute of Technology Chicago-Kent College of Law.
Cathy L. Burgess is senior counsel for regulatory law at the American Red Cross. From 1997 until 2003, she managed her own legal practice, representing numerous pharmaceutical and medical device companies before the FDA, CMS, Congress and in federal district court. Her representation has included compliance, enforcement and legislative work, including analysis and litigation regarding FDCA and FDA regulations in federal district court, and advising on compliance with FDA and CMS regulations.
Before forming her own firm, Cathy practiced law for nearly 10 years at Winston & Strawn and at predecessor firm Bishop, Cook, Purcell & Reynolds. She was the No. 2 person on the defense team in United States v. Barr Laboratories, Inc., the leading case on the elements and scope of cGMPs for pharmaceutical companies. Cathy has published numerous articles and has lectured on FDA matters at industry seminars and for industry training programs. She earned her B.S. in Foreign Services from Georgetown University and her JD from the Columbus School of Law, The Catholic University of America.
This audio CD/transcript is a must for professionals in drug, biotech and device companies, including:
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