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    • Ex-FDA Official Publishes White Paper on Navigating Quality System Regulations for Combination ProductsJune 26th, 2007

      In a recently published white paper (registration required), Steven Richter, a former FDA official and President and Chief Scientific Officer of Microtest Labs, discusses the regulatory challenges facing combination products.  The market for combination products is growing such that it is estimated to reach approximately …

    • Ill. District Court Recommends Reversal of HHS Federal Healthcare Program Exclusion DecisionMay 11th, 2007

      On April 30, 2007, the District Court for the Southern District of Illinois issued its opinion in Connell v. Secretary of Health and Human Servs., No. 05-cv-4122-JPG, 2007 WL 1266575 (S.D. Ill. Apr. 30, 2007) concerning a final decision by the Secretary of the Department …

    • FDA Law Blog LaunchMarch 6th, 2007

      Welcome to the FDA Law Blog, the blog of Hyman, Phelps & McNamara, P.C.  We’ll be covering topics of interest to FDA-regulated companies, fellow food and drug and healthcare lawyers and regulatory personnel, as well as people just generally interested in FDA law. First and foremost, …