Administrative Agency Updates

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FDA to Strengthen Oversight of Certain In Vitro Diagnostic Devices

In the wake of a new Medicare reimbursement framework, FDA plans stricter regulation of some in vitro diagnostic devices. On July 31, 2014, the U.S. Food and Drug Administration (FDA; Agency) announced its intent to...more

OMHA Announces Two New Programs to Process Administrative Law Judge (ALJ) Hearings More Efficiently

Earlier this year, the Office of Medicare Hearings and Appeals (OMHA) announced that for most hearing requests received after April 1, 2013, it will be deferring assignment of ALJs. OMHA’s announcement is available on its...more

ERISA ATTORNEY FEES – 1st Circuit: Court Remand to Claims Administrator “because the record is insufficient for de novo review” is...

You have seen this issue before: The court remands the ERISA-governed long term disability claim for further consideration by the claims administrator because the administrative record was insufficient for de novo review....more

Court Allows ESA Claims Involving Oversight of Pesticides to Move Forward

In Center for Biological Diversity v. Environmental Protection Agency, No. 11-cv-00293-JCS, plaintiffs alleged that the Environmental Protection Agency (EPA) violated section 7 of the Endangered Species Act by failing to...more

Finally Certainty About Licensing SPVs Under the FCA Consumer Credit Regime

From 1 April 2014, responsibility for the regulation of consumer credit in the UK was transferred from the Office of Fair Trading (“OFT”) to the Financial Conduct Authority (“FCA”), drawing certain activities relating to...more

FDA Requests Comments and Issues Notice of Public Hearing Related to Implementation of GDUFA

On August 19, 2014, the U.S. Food and Drug Administration (FDA) issued in the Federal Register a request for comment and notice of public hearing on a variety of topics relating to its implementation of the Generic Drug User...more

You’re NOT Paranoid – the Agencies ARE Ganging Up

Feeling a bit paranoid these days, especially where government oversight or agency investigations are involved? Your perception of reality is probably being driven less by paranoia and more by the upticks in government...more

MOL permits employer to have multi-workplace joint health and safety committee, union’s challenge dismissed

A union has lost a request to suspend a Ministry of Labour Director’s order allowing a school board to establish a multi-workplace joint health and safety committee. The Ontario Occupational Health and Safety Act...more

The SEC Tackles Technicality

Within several months of Securities and Exchange Commission Chair Mary Jo White’s announcement in late 2013 of a commitment to improving the SEC’s trial readiness, the Commission suffered a number of losses in federal...more

Health Care Update - August 2014 #3

In This Issue: - Stakeholders Urge FDA to Provide Clarity on Biosimilars - Ebola Crisis Continues - Implementation of the Affordable Care Act - Other Federal Regulatory Initiatives - Other...more

Critical Habitat and the Endangered Species Act: Proposed Revisions to Fundamental Regulatory Concepts

On May 12, 2014, the U.S. Fish and Wildlife Service (“FWS”) and the National Marine Fisheries Service (collectively, the “Services”) issued notices of proposed rules and a proposed policy related to the designation of...more

If A Tree Falls In The City, Is It Serving A Public Purpose?

Today’s posting has nothing to do with corporate law and everything to do with trees. On November 30 and December 1, 2011, the City of Pasadena experienced an unusually violent windstorm. Wind speeds in excess of 100 miles...more

Two Recent Cases May Indicate Expansion of the NLRB’s Position Regarding Organizing Activity

In June, the National Labor Relations Board (NLRB) ruled that Starbucks violated labor law by firing a worker, union supporter Joseph Agins, who used profanity in front of customers. In 2010, the NLRB found that Starbucks...more

Court of Appeal Clarifies Requirements for Public Input on Development Agreements

Due process rights to notice and a public hearing for those who may be affected do not apply to a public agency’s consideration of approval of a development agreement, an appellate court has ruled. In addition, the First...more

The NLRB Does It Again!

The National Labor Relations Board (NLRB) recently ratified all the decisions made by the NLRB, including those made in administrative and personnel matters, during the period of time when it did not have a proper quorum....more

Revenue-Driven Licensing Activities Fail to Satisfy Domestic Industry Requirement for ITC Action

The ALJ terminated the ITC investigation upon granting respondent's motion for summary judgment for lack of domestic industry, finding that the complainant's (a licensing entity) patent-related activities were solely...more

California District Court Dismisses ESA Section 7 Case for Failure to Allege that Agency Action Took Place on the "High Seas"

On August 12, a judge for the Northern District of California granted a motion to dismiss claims alleging that a federal agency violated section 7 of the Endangered Species Act (ESA) by failing to consult with federal...more

National Transportation Safety Board Procedures to Change: Comments Due by October 14, 2014

If you have participated in the investigation of a major transportation calamity, you are likely familiar with the bold yellow lettering on the blue jackets of National Transportation Safety Board (NTSB) investigators. These...more

FDA Releases Guidelines for 12-Year Period of Reference Product Exclusivity for Section 351(a) Biologics

The U.S. Food and Drug Administration (“FDA”) has released its latest “Guidance for Industry” regarding the FDA’s interpretation of the Biologics Price Competition and Innovation Act of 2009 (“BPCIA”), which established an...more

Pennsylvania Issues Regulations Under Excessive Overtime in Health Care Act

On July 19, 2014, the Pennsylvania Department of Labor and Industry published new regulations to implement certain provisions of the Prohibition of Excessive Overtime in Health Care Act, 43 P.S. §§ 932.1 to 932.6 (the "Act")....more

FDA Releases Another Prospective Guidance

On August 5th, the U.S. Food and Drug Administration issued a "Guidance for Industry" entitled "Reference Product Exclusivity for Biological Products file under Section 351(a) of the PHS Act." Before setting forth the first...more

NLRB Continues Its Busy Summer with Important New Decisions on Weingarten Rights, Noel Canning Issues

The National Labor Relations Board continued its busy summer over the past two weeks. First, the Board issued a decision reaffirming the importance it places on an employee’s Weingarten rights, even if they impede an...more

FDA Takes First Steps Towards Regulating Laboratory Developed Tests

On July 31, the Food and Drug Administration (FDA or “the Agency”) notified Congress that it intends to issue draft guidance proposing a Framework for Regulatory Oversight of Laboratory Developed Tests (LDTs) (“Draft...more

Fifth Circuit Holds that the Army Corps of Engineers' Jurisdictional Determination Does Not Constitute a Reviewable "Final Agency...

On July 30, 2014, the United States Court of Appeals for the Fifth Circuit held that the issuance of a jurisdictional determination (JD) by the U.S. Army Corps of Engineers (Corps) is not a final agency action subject to...more

ITC ALJ Breaks New Ground, Further Heightening the DI Requirement for NPEs in § 337 Cases

According to a recent initial determination by an Administrative Law Judge of the International Trade Commission, a purely revenue-driven NPE cannot prove the existence of a domestic industry by relying solely on the...more

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