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Results: 11-20 of 68

FDA releases draft guidance concerning clinical trials

  • Sidley Austin LLP
  • -
  • USA
  • -
  • December 6 2012

On November 20, the Food and Drug Administration (FDA) took another step toward modernizing clinical trial oversight by issuing two draft guidance documents related to the conduct of clinical trials

EU court rules on classification of certain borderline products as medical devices

  • Sidley Austin LLP
  • -
  • European Union
  • -
  • December 3 2012

In a judgment published on November 22, 2012, the Court of Justice of the European Union (CJEU) confirmed that products intended for the investigation of physiological processes only fall within the scope of the EU Medical Device Directive (9342EEC), as implemented into EU Member State legislation, if the products are intended for a medical purpose

Draft final PFS and HOPPS Rules' drug provisions

  • Sidley Austin LLP
  • -
  • USA
  • -
  • November 16 2012

On November 1, 2012, the Centers for Medicare and Medicaid Services (“CMS”) released both the Medicare Physician Fee Schedule (“PFS”) and Hospital Outpatient Prospective Payment System (“HOPPS”) Final Rules with comment period

Significant overhaul of EU medical devices regime planned

  • Sidley Austin LLP
  • -
  • European Union
  • -
  • October 29 2012

On 26 September 2012, the European Commission published the proposals for two new Regulations intended to replace the EU directives that govern medical devices intended to be placed on the EU market

Implementation of EU API import restriction

  • Sidley Austin LLP
  • -
  • European Union
  • -
  • October 12 2012

The European Commission recently sent a letter to EU pharmaceutical trade associations requesting information on how the pharmaceutical industry will adapt to the new EU import rules for Active Pharmaceutical Ingredients (“API”) that will apply as of 2 July 2013

China promulgates a PSUR guidance for approved drugs

  • Sidley Austin LLP
  • -
  • China
  • -
  • September 25 2012

On September 13, 2012, the State Food and Drug Administration (“SFDA”) published a Technical Guidance for the Periodic Safety Update Report for Marketed Drugs (the “PSUR Guidance”

FDA issues warning letter to Lancôme for anti-aging claims

  • Sidley Austin LLP
  • -
  • USA
  • -
  • September 14 2012

On September 7, 2012, the compliance office within the Center for Food Safety and Applied Nutrition (CFSAN) at FDA issued a Warning Letter to Lancôme USA, a subsidiary of L’Oréal, regarding several anti-aging skin care products being marketed as cosmetics

Chinese Ministry of Health issues guidance to strengthen anti-bribery control at public hospitals

  • Sidley Austin LLP
  • -
  • China
  • -
  • September 6 2012

On August 1, 2012, the Ministry of Health of China (“MOH”) issued the draft Guidance on Strengthening Anti-Bribery Control at Public Hospitals

New Chinese medical device GCP unveiled for public comments

  • Sidley Austin LLP
  • -
  • China
  • -
  • September 4 2012

The Chinese State Food and Drug Administration (“SFDA”) published the revised Medical Device Good Clinical Practice (“Medical Device GCP”) in late August and is soliciting public comments until September 30, 2012

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