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On the Heels of 21st Century Cures Enactment, FDA Finalizes Medical Device Accessories Guidance

by chuck_ltd | 6 Jan, 2017 | Medical Devices

On December 30, 2016, the Food and Drug Administration (FDA or the Agency) issued a final guidance document entitled Medical Device Accessories – Describing Accessories and Classification Pathways for New Accessory Types. This guidance generally affirms the framework...

Revisions to Clinical Data Publication Guidance extends scope of EMA disclosure power

by chuck_ltd | 22 Dec, 2016 | CHCUK News & Articles, EU Clinical Trials Regulation, News, Publication Guidelines

On 9 December 2016, the European Medicines Agency (“EMA”) organised a webinar for industry associations. At the webinar, the EMA presented an update concerning the implementation of the EMA policy on publication of clinical data for medicinal products for human use...

EMA Begins EudraVigilance Training Courses

by chuck_ltd | 14 Apr, 2016 | CHCUK News & Articles, News

The European Medicines Agency (EMA) has begun running a series of modular training courses to support stakeholders in using EudraVigilance, the centralized database for managing information on suspected adverse reactions reported with medicines authorised in the...

New French Transparency Regulations Ruled Valid

by chuck_ltd | 1 Feb, 2016 | CHCUK News & Articles

The law on modernisation of the French health system adopted on 17 December 2015 introduced, amongst other things, changes to the existing sunshine regulations which require industry to make public the existence of certain agreements with, and benefits provided to,...

New French Regulations put HCP-Industry Relationships in the Spotlight

by chuck_ltd | 24 Dec, 2015 | CHCUK News & Articles, News, NIS, Pragmatic Trials, Professional Standards, Real Word Evidence, Registry, Virtual Clinical Research

On 17 December 2015, the French National Assembly adopted a law on modernisation of the French health system (the “Public Health Law”).  Key provisions will bring changes to how the pharmaceutical and medical device industries interact with HCPs, by...
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