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Results: 1-10 of 24

China proposes new ADR reporting rule

  • Sidley Austin LLP
  • -
  • China
  • -
  • July 30 2009

On June 30, the Ministry of Health ("MOH") and the State Food and Drug Administration ("SFDA") of China issued a draft revision of the Rule on Adverse Drug Reaction Reporting and Monitoring (the "Reporting Rule"

FDA draft guidance on Dear Health Care Provider letters carries potentially significant products liability implications

  • Sidley Austin LLP
  • -
  • USA
  • -
  • November 19 2010

The Food and Drug Administration (FDA) draft Guidance (Guidance) addressing the content and format of Dear Health Care Provider (DHCP) letterswhich are sometimes called "Dear Doctor" lettersis the first substantive guidance from FDA on this issue

FDA proposes two groundbreaking food safety rules

  • Sidley Austin LLP
  • -
  • USA
  • -
  • January 8 2013

On January 4, 2013, the U.S. Food and Drug Administration ("FDA" or the "Agency") proposed two major, long-awaited rulemakings required by the Food Safety

China encourages pharmaceutical companies to timely pursue new GMP certification

  • Sidley Austin LLP
  • -
  • China
  • -
  • January 15 2013

In 2010, China's State Food and Drug Administration ("SFDA") issued a new version of its Good Manufacturing Practice (the "GMP") regulations, which

SFDA to enforce blacklist system for unsafe drug and device products

  • Sidley Austin LLP
  • -
  • China
  • -
  • August 21 2012

Beginning October 1, 2012, China’s State Food and Drug Administration (SFDA), including its provincial counterparts, will implement a nationwide information disclosure system called the Drug Safety Blacklist (“Blacklist”), which includes medical device products as well

New age of Singapore’s regulations of medical devices

  • Sidley Austin LLP
  • -
  • Singapore
  • -
  • June 9 2011

In the past several years, Singapore has been in the process of revamping its regulatory regime for health products

European Union adopts falsified medicines directive

  • Sidley Austin LLP
  • -
  • European Union
  • -
  • June 7 2011

On May 27, 2011 the Council of the European Union (Council) adopted a directive aimed at preventing falsified medicines from entering into the legal supply chain

Senate passes food safety legislation: food product and dietary supplement implications

  • Sidley Austin LLP
  • -
  • USA
  • -
  • December 7 2010

On November 30, 2010, the Senate approved the long-awaited Food Safety Modernization Act, S. 510, by a 73-25 vote

Major vaccine standards change in China

  • Sidley Austin LLP
  • -
  • China
  • -
  • January 24 2011

The State Food and Drug Administration ("SFDA") recently issued the Notice for Further Strengthening the Supervision of Quality and Safety of Vaccines ("Vaccine Notice"

CMS seeks comments on its long-awaited Sunshine Act proposed rule

  • Sidley Austin LLP
  • -
  • USA
  • -
  • December 21 2011

The Centers for Medicare & Medicaid Services recently published a proposed rule implementing the Physician Payment Sunshine Act (section 6002 of the Affordable Care Act