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.
Monthly Archives: August 2014
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!
- BIG MAC ATTACK : NLRB General Counsel Argues Franchisees and McDonald’s Are Joint Employers from Epstein Becker & Green
- Ohio Supreme Court Ruling simplifies contract drafting, negotiation, and enforcement from McDonald Hopkins
- Supreme Court Rules Early Dismissal of Cases Beneficial from Fogler, Rubinoff
- Notice of resignation or immediate termination from Robinson Sheppard Shapiro
- Recent court decision on tiered dispute resolution clauses from Fladgate
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…
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…