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132 results found

Article

Ropes & Gray LLP | China, Global | 7 Jan 2019

Life Sciences: product regulation and liability in China

A structured guide to product regulation and liability laws in China

Article

Ropes & Gray LLP | China, Global | 7 Jan 2019

Clinical trials in China

A structured guide to clinical trials in China

Article

Arent Fox LLP | USA | 28 Jun 2017

FDA Publishes Action Plan Designed to Address Generic Drug Competition Barriers

On June 21, the Food and Drug Administration announced a Drug Competition Action Plan in order to attempt to address ways that the agency's rules have

Article

Baker & Hostetler LLP | USA | 25 Apr 2017

Capitol Hill Healthcare Update

Although House Republicans made progress on bridging ideological differences over how to replace the Affordable Care Act (ACA), GOP leaders say not to

Article

Marshall Gerstein & Borun LLP | USA | 24 Mar 2017

Pending Bill Would Deliver More Judicial Scrutiny to USPTO and FDA Rules

The House of Representatives recently sent to the Senate its bill (H.R.5) that combines six previous regulatory reform bills, including, as Title II

Article

Gowling WLG | Canada | 30 Nov 2016

Federal Court of Appeal grants minister of health the right to be wrong

In an October 12 2016 decision (Teva Canada Limited v Pfizer Canada Inc, 2016 FCA 248) the Federal Court of Appeal upheld two decisions of the

Article

Venable LLP | USA | 21 Oct 2016

FDA Final Rule Implementing and Amending Regulations regarding Title XI of Medicare Prescription Drug, Improvement, and Modernization Act (“MMA”) of 2003

On October 6, 2016, FDA published a Final Rule in the Federal Register to implement and amend certain regulations regarding the MMA. These changes

Article

TozziniFreire Advogados | Brazil | 28 Sep 2016

ANVISA publishes new rules for transferring marketing authorisations

On August 25 2016 the Health Surveillance Agency (ANVISA) published Resolution 1022016, issuing new rules regarding the transfer of: marketing

Article

Fenwick & West LLP | USA | 15 Aug 2016

Will the Supreme Court review whether FDA-mandated bioequivalence testing to maintain approval falls within the 271(e)(1) safe harbor?

The Supreme Court has been asked to review whether the safe harbor established by 35 U.S.C. 271(e)(1) encompasses a generic drug manufacturer’s

Article

King & Wood Mallesons | China | 1 Aug 2016

Highlights on the draft rules of drug registration

On July 25, 2016, the China Food and Drug Administration ("CFDA") published the Administrative Provisions for Drug Registration (Revision) (the

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