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Results: 1-10 of 67

China develops new rules to simplify medical device re-registration process

  • Sidley Austin LLP
  • -
  • China
  • -
  • April 1 2013

China's newly restructured food and drug regulatory agency, the China Food and Drug Administration ("CFDA"), has published new draft rules to

SFDA 2012 Anual Drug Review Report highlights innovator focus

  • Sidley Austin LLP
  • -
  • China
  • -
  • March 8 2013

On February 28, 2013, the Center for Drug Evaluation of the State Foodand Drug Administration ("CDE"), the key agency reviewing safety andefficacy

Top 10 steps global life sciences companies should take in 2013

  • Sidley Austin LLP
  • -
  • USA
  • -
  • March 1 2013

Engage in US budget and deficit reduction process. As governments, including the US and China, search for the means to fund priorities or reduce

FDA finalizes guidance to address potential bias and conflicts of interest in clinical investigations

  • Sidley Austin LLP
  • -
  • USA
  • -
  • March 1 2013

FDA has finalized its guidance on financial disclosure for clinical investigators. A draft of the guidance, published in May 2011, was developed in

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

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