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Results: 1-10 of 78

FDA moves forward with program for Medical Device Development Tools

  • Sidley Austin LLP
  • -
  • USA
  • -
  • September 8 2014

On August 15, 2014, FDA announced that it is soliciting proposals to participate in a pilot program for Medical Device Development Tools (MDDTs

8th Circuit affirms dismissal of FCA claim, offering guidance on the application of the public disclosure bar

  • Sidley Austin LLP
  • -
  • USA
  • -
  • August 18 2014

On August 7, 2014, the Eighth Circuit affirmed the dismissal of a qui tam False Claims Act suit, and in doing so offered helpful guidance regarding

New FDA informed consent draft guidance broadens scope of sponsor disclosure obligations

  • Sidley Austin LLP
  • -
  • USA
  • -
  • July 22 2014

On July 15, 2014, the U.S. Food and Drug Administration ("FDA" or the "Agency") issued a draft guidance document, entitled "Informed Consent

Decoding FDA: five things to know about the FDA’s June 6 response to the MIWG citizen petition concerning off-label promotion

  • Sidley Austin LLP
  • -
  • USA
  • -
  • June 18 2014

On June 6, 2014, FDA sent a letter to counsel for the Medical Information Working Group (MIWG), a coalition of biopharmaceutical and medical

Sidley Austin LLP global pricing newsletter - volume three 2014

  • Sidley Austin LLP
  • -
  • Brazil, Canada, China, European Union, France, Germany, India, United Kingdom, USA
  • -
  • April 15 2014

On October 21, 2013, Brazil’s National Agency of Supplemental Health enacted Normative Resolution 388, which mandated that all private healthcare

China amends its cornerstone Regulation on Medical Devices

  • Sidley Austin LLP
  • -
  • China
  • -
  • April 7 2014

On March 31, 2014, China's State Council published the amended Administrative Regulation on Medical Devices, which will become effective on June 1

China issues implementation rules for its new pharmaceutical and medical device blacklist system

  • Sidley Austin LLP
  • -
  • China
  • -
  • March 19 2014

On December 27, 2013, China's National Health and Family Planning Commission (NHFPC) published an agency rule to update the "blacklist system" for

4th Circuit affirms dismissal of FCA suit premised on alleged violations of FDA GMP regulations

  • Sidley Austin LLP
  • -
  • USA
  • -
  • February 26 2014

On February 21, 2014, the Fourth Circuit upheld the dismissal of a former employee's False Claims Act suit against Omnicare, Inc. ("Omnicare"

China formulates special regulatory pathway for innovative medical device products

  • Sidley Austin LLP
  • -
  • China
  • -
  • February 11 2014

China Formulates Special Regulatory Pathway for Innovative Medical Device Products On February 7, 2014, the China Food and Drug Administration (CFDA

Supreme Court of Louisiana overturns $330 million judgment in off-label marketing case

  • Sidley Austin LLP
  • -
  • USA
  • -
  • February 4 2014

Last week, the Supreme Court of Louisiana reversed a $330 million judgment ($258 million in penalties, $70 million in attorney fees, and $3 million