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On March 1, 2007, the D.C. Circuit Court of Appeals heard an oral argument in Abigail Alliance v. von Eschenbach. Previously, a divided court of appeals had ruled that where…
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…510(k) program is an excellent approach to the premarket review of medium risk medical devices, and has strengths that critics have overlooked. Click here to view/download the video of the…
…that FDA “will assign the combination product to the agency component that regulates other combination products that present similar questions of safety and effectiveness with regard to the combination product…
Bob Dormer will be presenting the “Generic Drug Regulatory Update” at the FDA/OCRA 12th Annual Educational Conference Irvine Marriott 18000 Von Karman Avenue Irvine, CA…
Brian Donato will be presenting on “Legal Issues” at the OCRA Design Controls for Devices and Drugs meeting. Irvine Marriott 18000 Von Karman Avenue Irvine, CA…
…B. Clissold (202) 737-7545 dclissold@hpm.com Alexander J. Varond (202) 737-4594 avarond@hpm.com James E. Valentine* (202) 724-1745 jvalentine@hpm.com *Admitted only in Maryland. Work supervised by the Firm while D.C. application pending….