Approval

News & Analysis as of

FDA Deputy Commissioner Details Agency’s Priorities In Recent Speech

In This Issue: - Snapshot of the Agency: FDA-regulated products - Recent Public Health Milestones - Innovative Programs at FDA ..A. FDA has a number of programs intended to speed the availability of...more

Significant Changes to the Regulatory Approval Process

Recent court decisions and legislative changes have marked significant changes to the regulatory approval process. This month, Alberta courts rendered decisions with respect to Alberta energy resource development projects by...more

The FDA’s 510(k) Approval Process in Medical-Device Litigation

Any litigator knows evidence makes or breaks a case. One piece of admissible evidence may not determine a matter outright, but it may be that crucial nudge for a jury to tip the scales of justice for one side or the other. In...more

Public Entities' Discretion in Approving Construction Designs Strengthened - Recent Decision Rejects Adding Requirements for...

The California Court of Appeal recently held that one of the three elements needed to establish the design immunity defense -- discretionary approval -- may be established either by evidence of appropriate discretionary...more

New Development Extension Opportunities Provided by the 2013 Florida Legislature

The Florida Legislature has provided numerous extensions for development permits and approvals over the past several years, which have typically required that the holder of the permit or approval provide notice to the issuing...more

Ontario Releases Draft Asset Transfer Regulations

On July 2, 2013, Ontario’s Ministry of Finance released for public comment draft regulations that would give life to the new pension asset transfer provisions in Ontario’s Pension Benefits Act (PBA) that were inserted in the...more

Higher Education Highlights - Spring 2013

In This Issue: - U.S. Supreme Court to Rule on Causation Factor in Retaliation Claims - Student Sues University Over the Right to Keep a Guinea Pig in a College Dorm for Emotional Support - Delaware...more

China FDA Publishes Draft Measures to Accelerate Medical Device Approvals

The China Food and Drug Administration (previously known as the State Food and Drug Administration) (the “CFDA”) has published drafts of two tentative measures, Fast Track Approval Process of Innovative Medical Devices and...more

REGULATORY: EU Competition Law: Twenty Million Euro: The Price for Merging Without European Commission Approval by Suzanne Rab

The European Union’s second-highest court upheld a fine of EUR 20 million (approximately USD 26 million) against Electrabel (a division of GDF Suez) for early implementation of a merger without notifying and seeking prior...more

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