Sarah Cowlishaw

Sarah Cowlishaw

Sarah Cowlishaw's practice focuses on life sciences regulatory and commercial law for pharmaceutical,medical device,food,and consumer products.Her advice on general regulatory matters includes borderline determinations,food classifications,adverse event and other reporting obligations,manufacturing controls,and labeling and promotion.Ms.Cowlishaw also advises on regulatory aspects of corporate/commercial deals,particularly regulatory due diligence.

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UK NICE Considers Restrictions on Hip Replacement Implants

The UK National Institute for Health and Care Excellence (NICE) has issued 德赢真人视讯draft guidance recommending tightening standards for hip replacement devices.  If adopted,the tougher standards could force the National Health Service (NHS) to stop using a significant number of existing devices,with obvious impacts on manufacturers of these products.… Continue Reading

Advocate General Opinion on Reclassification of Medical Devices

On May 30,2013,Advocate General Sharpston delivered an opinion on a request for a preliminary ruling from the Finnish national courts concerning the laws governing reclassification of medical devices (Advocate General: Opinion,Case C-109/12).  The Advocate General's opinion does not bind the Court of Justice of the European Union (CJEU).  However,in the majority of … Continue Reading

EU Regulation on Electronic Instructions for Use of Medical Devices

Commission Regulation (EU) 207/2012 on electronic instructions for use of medical devices (the Regulation) came into force in the EU last month.  The Regulation allows manufacturers of certain types of medical devices and accessories to replace paper form instructions of use with an electronic substitute.  It aims to reduce environmental burden and improve the competitiveness … Continue Reading