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European Commission allows submission of new data in support of probiotic health claims
- Sidley Austin LLP
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- European Union
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- 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
China's new SFDA priorities
- Sidley Austin LLP
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- China
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- 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
New age of Singapore’s regulations of medical devices
- Sidley Austin LLP
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- Singapore
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- June 9 2011
In the past several years, Singapore has been in the process of revamping its regulatory regime for health products
New EU rules recognize tolerance level for traces of GM material in feed
- Sidley Austin LLP
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- European Union
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- 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 Union adopts falsified medicines directive
- Sidley Austin LLP
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- European Union
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- 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
Senate passes food safety legislation: food product and dietary supplement implications
- Sidley Austin LLP
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- USA
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- December 7 2010
On November 30, 2010, the Senate approved the long-awaited Food Safety Modernization Act, S. 510, by a 73-25 vote
CMS seeks comments on its long-awaited Sunshine Act proposed rule
- Sidley Austin LLP
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- 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 Chinese medical device GCP unveiled for public comments
- Sidley Austin LLP
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- China
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- 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
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- China
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- 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
EU court rules on classification of certain borderline products as medical devices
- Sidley Austin LLP
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- European Union
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- 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
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- Author - Scott Bass
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