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News bytes
  • Shook Hardy & Bacon LLP
  • USA
  • June 21 2012

The Food and Drug Administration seeks comments by August 13, 2012, on draft and revised draft guidances for industry describing product-specific bioequivalence recommendations regarding the design of studies to support abbreviated new drug applications.


News bytes
  • Shook Hardy & Bacon LLP
  • USA
  • March 1 2012

The Food and Drug Administration (FDA) releases a final guide dated February 2012 titled “Guidance for Industry: Early Clinical Trials with Live Biotherapeutic Products: Chemistry, Manufacturing, and Control Information.”


Newsbytes
  • Shook Hardy & Bacon LLP
  • USA
  • June 16 2011

The Food and Drug Administration (FDA) announces the availability of guidance for industry and investigators on the enforcement of safety reporting requirements for investigational new drug applications and bioavailability bioequivalence studies.