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FDA issues draft guidance on de novo classification process
  • King & Spalding LLP
  • USA
  • October 5 2011

On October 3, 2011, FDA issued a draft guidance entitled, “De Novo Classification Process (Evaluation of Automatic Class III Designation).”


FDA issues draft guidance on mobile medical applications
  • King & Spalding LLP
  • USA
  • August 1 2011

The U.S. Food and Drug Administration (FDA) recently released its “Draft Guidance for Industry and Food and Drug Administration Staff on Mobile Medical Applications.”


Forest Labs announces hhs-oig contemplating exclusion of its CEO
  • King & Spalding LLP
  • USA
  • May 2 2011

Forest Laboratories, Inc. (Forest Labs) announced that the Office of Inspector General of the Department of Health and Human Services notified Forest Labs’ CEO and President, Howard Solomon, by letter on April 12, 2011, that it was considering excluding him from participation in federal healthcare programs because he is an individual “associated with” Forest Labs.


FDA Food Safety Modernization Act imposes new requirements on imported food
  • King & Spalding LLP
  • USA
  • February 28 2011

On January 4, 2011, President Obama signed into law the FDA Food Safety Modernization Act (S. 510) (FSMA), which amends the Federal Food, Drug, and Cosmetic Act (the FDC Act).


FDA's recent remarks about 510(k) changes
  • King & Spalding LLP
  • USA
  • November 8 2010

Elaine Tseng and Laurie Clarke, who are partners in King & Spalding's FDA & Life Sciences Practice Group, recently participated in panel discussions with Christy Foreman, the Acting Director of FDA's Office of Device Evaluation (ODE), about changes to the 510(k) program.


Senior FDA officials share 510(k) and enforcement insights at King & Spalding’s Device Summit
  • King & Spalding LLP
  • USA
  • October 22 2010

King & Spalding's October 13-14, 2010, East Coast Device Summit featured question and answer sessions regarding the Food and Drug Administration's (FDA or the Agency) 510(k) program and enforcement activities with two senior officials in the FDA's Center for Devices and Radiological Health (CDRH).


Mark S. Brown
  • King & Spalding LLP


Mike Paulhus
  • King & Spalding LLP

Fred Degnan
  • King & Spalding LLP