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Smart & Biggar | Canada | 7 Mar 2018

Consultation on use of foreign-sourced reference product as Canadian reference product

Health Canada recently published a notice soliciting comments and recommendations from stakeholders regarding potential changes to its guidance document on the use of a foreign-sourced reference product as a Canadian reference product. Stakeholder feedback should be submitted to Health Canada by March 18 2018, preferably in electronic form.
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Smart & Biggar | Canada | 28 Feb 2018

Apotex granted damages for delayed FDA approval of two products

The Ontario Superior Court of Justice recently held that Apotex was entitled to damages for losses resulting from delays in the US Food and Drug Administration's approval of two of its products, which had been caused by contractual breaches and negligence on the part of MDS Pharma Services. Due to MDS's failure to comply with the US regulatory framework for conducting bioequivalence studies,......
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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…
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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…
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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…
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Ropes & Gray LLP | China | 18 Jan 2017

CFDA solicits comments on pharmaceutical GCPs

The China Food and Drug Administration recently proposed the most comprehensive revisions of the pharmaceutical good clinical practices (GCPs) in 13 years. The revisions have rewritten the articles of the existing pharmaceutical GCPs and provide general principles for conducting clinical studies in China; guidance on the roles and responsibilities of ethics committees, investigators and......
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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…
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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…
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Ropes & Gray LLP | China | 12 Oct 2016

CFDA clarifies legal consequences of clinical trial data inspections

China's recent drug regulatory reform has emphasised that clinical trial data must be authentic and reliable. However, the legal consequences for breaching data integrity requirements in clinical trials remain ambiguous. In light of this, the China Food and Drug Administration recently issued the draft Guideline for Handling Issues Identified in Clinical Trial Data Inspections, which aims to......
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TozziniFreire Advogados | Brazil | 28 Sep 2016

ANVISA publishes new rules for transferring marketing authorisations

The Health Surveillance Agency recently issued new rules regarding the transfer of marketing authorisations for certain products. Among other things, the rules enable the transfer of marketing authorisations and good practice certificates in transactions involving the sale and purchase of assets, without requiring the companies involved to complete a corporate transaction.
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