• where experts go to learn about FDA
    • Generic DEPAKOTE Litigation Update: Nu-Pharm Appeals District Court DecisionApril 3rd, 2008

      Earlier this year, we reported on the U.S. District Court for the District of Columbia’s January 24, 2008 order dismissing Nu-Pharm Inc.’s complaint against FDA seeking declaratory and emergency injunctive relief with respect to Nu-Pharm’s ANDA #77-615 for a generic version of Abbott Laboratories’ DEPAKOTE …

    • Foods v. Drugs: FDAAA § 912 RevisitedApril 2nd, 2008

      In our October 2007 summary and analysis of the FDA Amendments Act (“FDAAA”), Hyman, Phelps & McNamara, P.C. noted that FDAAA § 912, concerning a new prohibition against foods to which drugs or biological products are added, is “of potential significance to the development of …

    • Playing “Hard Ball” With FDA Might Lead to Criminal ProsecutionApril 1st, 2008

      The latest FDLI Update article by Hyman, Phelps & McNamara, P.C.’s Riëtte van Laack and John R. Fleder discusses a recent court ruling showing the potential perils faced by a company and its officers who aggressively defend their position.   In United States v. Kaminski, the …

    • “Andy’s Take” (‘Nuff Said)April 1st, 2008

      Welcome to the wonderful world of blogging, Dr. von Eschenbach!  Yep, just like his boss, Department of Health and Human Services Secretary Michael Leavitt, who started “Secretary Mike Leavitt’s Blog” last year, FDA Commissioner, Dr. Andrew von Eschenbach, has started a blog as well – …