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Significant overhaul of EU medical devices regime planned

Sidley Austin LLP
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European Union
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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

SFDA finalizes its rules on packaging and labeling of imported medical devices

Sidley Austin LLP
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China
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October 9 2012

On September 24, 2012, China’s State Food and Drug Administration (SFDA) issued the final Notice on Further Regulating Labeling and Packaging of Medical Devices Manufactured Overseas (the “Notice”), which will become effective on April 1, 2013

FDA issues warning letter to Lancôme for anti-aging claims

Sidley Austin LLP
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USA
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September 14 2012

On September 7, 2012, the compliance office within the Center for Food Safety and Applied Nutrition (CFSAN) at FDA issued a Warning Letter to Lancôme USA, a subsidiary of L’Oréal, regarding several anti-aging skin care products being marketed as cosmetics

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

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

Sidley Austin LLP
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USA
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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
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European Union
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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

ALJ opinion signals rejection of FTC’s rigorous substantiation requirements for food and dietary supplement claims

Sidley Austin LLP
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USA
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June 19 2012

Food and dietary supplement manufacturers can take some comfortat least for nowthat the Federal Trade Commission’s (FTC) recent consent decrees that impose on respondents draconian standards for advertising claims will not become the norm for future companies that run afoul of FTC advertising law

European Parliament calls for additional medical device safety measures

Sidley Austin LLP
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European Union
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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

Updates on international pricing issues for pharmaceutical and biologic products

Sidley Austin LLP
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China, European Union, France, Germany, United Kingdom, USA
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May 18 2012

Sidley Austin LLP’s Global Life Sciences Team is pleased to provide you with this Global Pricing Newsletter, the first in a periodic series updating clients and friends of the firm on pricing issues around the world that may have an impact on pharmaceutical and biologic manufacturers’ legal and business strategies

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Search results

Significant overhaul of EU medical devices regime planned

SFDA finalizes its rules on packaging and labeling of imported medical devices

FDA issues warning letter to Lancôme for anti-aging claims

New Chinese medical device GCP unveiled for public comments

SFDA to enforce blacklist system for unsafe drug and device products

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

Extended scope EU Penalties Regulation enters into force

ALJ opinion signals rejection of FTC’s rigorous substantiation requirements for food and dietary supplement claims

European Parliament calls for additional medical device safety measures

Updates on international pricing issues for pharmaceutical and biologic products

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