Monthly Archives: August 2014

Contrary to Misconceptions, a Final Guidance is Not a Final Rule

Earlier this week, a popular source of regulatory news published an article claiming FDA “finalized a new rule this week that prohibits manufacturers from using so-called “split-predicates”. (link) However, it appears that the article may instead be referencing the Final Guidance for Industry and Food and Drug Administration Staff entitled “The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)]” that FDA published earlier this week.  Unfortunately, as often occurs on the Internet, the post was disseminated by several other popular sources of regulatory news.

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Week of July 28, 2014 on ILNToday – A Roundup!

August is here already, and that means September is around the corner – fall is coming! It looks like we’re in for some storms on the east coast this weekend, so before building your ark, take a look through this week’s top posts!

 

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ILN Today Post

Changing roles

This article was previously published in RICS Building Surveying Journal.

Gillian Birkby examines the legal implications of Health and Safety Executive proposals on changes to the Construction (Design and Management) Regulations with an eye to how they will work in practice.

The Health and Safety Executive’s (HSE) aims in updating the CDM Regulations 2007 include improving worker protection, health and safety on smaller construction sites and discouraging bureaucracy. Where possible, it has implemented the government’s policy of reducing regulation, but at the same time incorporated the European mobile sites directive. More…

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ILN Today Post

Recent court decision on tiered dispute resolution clauses

Is an agreement to engage in “friendly discussions” before commencing arbitration enforceable?

Tiered dispute resolution clauses

Tiered dispute resolution clauses, also known as ‘escalation’ clauses, require the parties to undertake one or more forms of alternative dispute resolution (ADR), typically negotiation and/or mediation, before commencing formal litigation or arbitration proceedings. More…

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