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Results: 11-20 of 75

China amends major regulation on drug distribution
  • Sidley Austin LLP
  • China
  • February 25 2013

On January 22, 2013, the Ministry of Health of China published the amended Good Supply Practice for Drugs ("Drug GSP"). Drug GSP is one of the key


Amendments to proposed EU clinical trials regulation could have significant impact
  • Sidley Austin LLP
  • European Union
  • February 20 2013

Recently published amendments prepared by the Rapporteur of the European Parliament's responsible committee on the Commission's proposal to reform


FTC gives green light to Oklahoma PHO’s joint contracting proposal
  • Sidley Austin LLP
  • USA
  • February 20 2013

On February 13, 2013, the Federal Trade Commission ("FTC") staff issued an advisory opinion giving the go-ahead to an Oklahoma physician hospital


Increased FDA scrutiny of pre-approval communications continued in 2012
  • Sidley Austin LLP
  • USA
  • February 5 2013

Warning and untitled letters issued to prescription drug manufacturers in 2012 reflect continued FDA focus on pre-approval communications. FDA's


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


FDA releases draft guidance concerning clinical trials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the Food and Drug Administration (FDA) took another step toward modernizing clinical trial oversight by issuing two draft guidance documents related to the conduct of clinical trials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