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FDA Commissioner Dr. Margaret Hamburg delivered a key policy speech at FDLI on August 6, 2009. She promised a more aggressive posture with respect to enforcement and provided insight into those areas where FDA would focus. The FDLI Enforcement Conference is the single best source for understanding where FDA and other enforcement officials are planning to focus. No other conference brings together more government officials to speak about enforcement, and this year, more than ever, you can’t afford to miss what they had to say.

Not only is there likely to be more FDA heat for industry with Commissioner Hamburg at the helm, there is sure to be a surge in whistleblower cases, major criminal investigations, and increasing state prosecutor attention to pharmaceutical and medical device manufacturers and distributors. So, if you think you know FDA enforcement, think again. The laws and the enforcers have changed.

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