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Results: 11-20 of 25

Appeals Court issues important ruling in fraud and abuse case involving individual liability

  • Sidley Austin LLP
  • -
  • USA
  • -
  • July 31 2012

A recent D.C. Circuit decision in Friedman v. Sebelius overturned the exclusions of three Purdue pharma executives from participation in federal healthcare programs, holding that the Department of Health and Human Services acted arbitrarily in imposing extraordinarily lengthy exclusions

Extended scope EU Penalties Regulation enters into force

  • Sidley Austin LLP
  • -
  • European Union
  • -
  • July 13 2012

As of 2 July 2012, infringements of the EU’s paediatric and new pharmacovigilance rules fall within the scope of the revised EU Penalties Regulation and are now subject to financial penalties of up to 5 percent of the marketing authorization holder’s annual EU turnover

European Parliament calls for additional medical device safety measures

  • Sidley Austin LLP
  • -
  • European Union
  • -
  • June 18 2012

On 14 June 2012, the European Parliament (“EP”) adopted a Resolution calling on EU Member States and the European Commission to introduce and implement new measures aimed at ensuring the safety of medical devices

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

New EU rules recognize tolerance level for traces of GM material in feed

  • Sidley Austin LLP
  • -
  • European Union
  • -
  • July 21 2011

On 15 July, new rules entered into force in the EU that for the first time recognize a de facto tolerance level for traces of certain unauthorized genetically modified (“GM”) material in feed

European Commission allows submission of new data in support of probiotic health claims

  • Sidley Austin LLP
  • -
  • European Union
  • -
  • June 20 2011

The European Commission has opened a four-month window, starting on June 1 and closing on September 30, 2011, during which stakeholders can submit new data to Member States in support of certain probiotic health claims rejected by the European Food Safety Authority

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

China SFDA publishes new technical review guidelines for drugs

  • Sidley Austin LLP
  • -
  • China
  • -
  • March 29 2011

On March 23, 2011, the Center for Drug Evaluation (CDE) of the PRC State Food and Drug Administration (SFDA), the equivalent of the Center for Drug Evaluation and Research of the U.S. Food and Drug Administration, published new guidelines for its technical review of drug registration applications in China (the Guidelines), including applications for clinical studies (IND), applications for production and market approvals of new drugs (NDA), as well as applications for generic drugs (ANDA

China's new SFDA priorities

  • Sidley Austin LLP
  • -
  • China
  • -
  • February 1 2011

The General Commissioner of the State Food and Drug Administration ("SFDA") unveiled six key priorities of the agency in 2011 at the General Assembly of Food and Drug Administrations in China