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Results: 1-10 of 73

OIG updates provider self-disclosure protocol

  • Sidley Austin LLP
  • -
  • USA
  • -
  • April 19 2013

On April 17, 2013, the Department of Health and Human Services' Office of Inspector General ("OIG") released an Updated Provider Self-Disclosure

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

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

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

Global Pricing Newsletter: volume two

  • Sidley Austin LLP
  • -
  • China, Global, United Kingdom, USA
  • -
  • February 27 2013

Pharmaceutical and biologic manufacturers operate in an increasingly global economy where legal developments in one market may have cascading impacts

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

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

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

The omnibus HIPAA rule: a new era of federal privacy regulation

  • Sidley Austin LLP
  • -
  • USA
  • -
  • February 7 2013

On January 17, 2013, the Office for Civil Rights ("OCR"), U.S. Department of Health and Human Services ("HHS"), released a highly anticipated final

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