Administrative Agency Updates

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California Adopts Unprecedented “Yes Means Yes” Law, Changing the Way Colleges Must Investigate Sexual Assault Allegations

On September 28, 2014, California Governor Jerry Brown announced that he had signed SB967, the so-called “Yes Means Yes” bill into law, effectively changing the definition of “consent” for sexual partners on California...more

EPA Extends Comment Period on Significant Proposed Rule Under the Clean Water Act

The U.S. Environmental Protection Agency (“EPA”) announced that it has extended the comment period on a proposed rule that has the potential to significantly expand the authority of the EPA and the U.S. Army Corps of...more

FERC Reduces New England Transmission Owners’ Base ROE to 10.57 percent and Caps Total ROE at 11.74 percent

On October 16, 2014, the Federal Energy Regulatory Commission (FERC) issued Opinion No. 531-A, an order on the paper hearing it established in Opinion No. 531 regarding the long-term growth rate to use to calculate the New...more

Front End Changes and, Again, More DIR Columns

Since the beginning of the Medicare Part D program, CMS has introduced many reporting mechanisms for trying to understand drug pricing, price concessions, and the cost of providing services to Part D members. The tool CMS...more

Work Plan Signals Expanded Calif. Green Chemistry Program

As part of its Safer Consumer Products Regulation (SCPR) under California’s Green Chemistry Initiative, the Department of Toxic Substances Control (DTSC) on September 13, 2014 issued its Draft Priority Product Three-Year Work...more

Georgia Department of Community Health Ruling Jeopardizes FTC Action Against Phoebe Putney Health System, Inc.

On October 6, Ellwood F. Oakley III, an administrative hearing officer at Georgia’s Department of Community Health, reversed an initial staff determination that a new Certificate of Need (CON) would not be required if Phoebe...more

Do Lawyers Professional Liability Policies fall within the “no prejudice” amendments to New York’s Insurance Law for late notice?

The New York State Insurance Department has issued an ambiguous opinion taking the position that the amendment to Insurance Law §3420(a)(5), changing the “no prejudice” rule, applies to all liability policies, which arguably...more

IMDRF Releases International Framework for Regulating Device Software

On October 14, 2014, the International Medical Device Regulators Forum (IMDRF) issued a final version of “Software as a Medical Device: Possible Framework for Risk Categorization and Corresponding Considerations” (“the...more

The FDA Drug Approval Process in the Lifecycle of a Pre-Sales Revenue Biotechnology Venture Destined for IPO Success

The U.S. Food & Drug Administration regulates new drug approvals in a process that is extremely thorough, lengthy and expensive. Regulations apply to a drug candidate’s product development phase, the approval process and...more

Health Alert (Australia) - October 20, 2014

In This Issue: Judgements, Legislation, and Reports. Excerpt from Judgments: Commonwealth - 15 October 2014 - Gray v Richards [2014] HCA 40 - In 2003, a 10-year-old girl...more

Hospira, Inc. v. Burwell

Nature of the Case and Issue(s) Presented: Precedex is commonly used as a sedative. Specifically, the FDA has approved Precedex for two uses: (i) sedation of initially intubated and mechanically ventilated patients during...more

The Eleventh Circuit Reaffirms FCC’s Authority To Coordinate National TCPA Policy And Ensure Uniformity Of Enforcement in Mais v....

Courts that have confronted the application of the “prior express consent” requirement of the Telephone Consumer Protection Act, see 47 U.S.C. § 227 – a.k.a., the TCPA – have in the main taken their cues from and adhered to...more

FDA Publishes Four Key Supplemental Proposed Rules Under the Food Safety Modernization Act

The Food and Drug Administration (FDA) Food Safety Modernization Act (FSMA) was signed into law on January 4, 2011. This groundbreaking piece of legislation is aimed at improving FDA’s capacity to prevent, detect, and respond...more

FDA Issues Final Medical Device Recalls Guidance - Explains How to Distinguish Enhancements from Recalls

On October 15, 2015, the U.S. Food and Drug Administration’s Center for Devices and Radiological Health (“CDRH”) issued a final guidance document, Distinguishing Medical Device Recalls from Medical Device Enhancements (“Final...more

PTAB Offers Guidance Regarding Discovery in Inter Partes Reviews

Still confused about how much discovery you will be able to obtain in an IPR? Fear not, as two of the PTAB’s Administrative Patent Judges have weighed in with a primer on inter partes review discovery. ...more

Groundwater Basin Boundaries and Priorities Will Impose New Management Challenges on Local Agencies

The Sustainable Groundwater Management Act, which takes effect Jan. 1, requires that the Department of Water Resources categorize each of California’s 515 alluvial groundwater basins and subbasins as high, medium, low, or...more

The Year to Review Your Whistleblowing Policy

This year, the UK Financial Conduct Authority (FCA) has placed an increased emphasis on whistleblowing activity, both in relation to whistleblowing within authorised firms and the process of whistleblowing to the regulator....more

Court Applies MMBA Meet and Confer Requirement to Reorganization of Police Department Command Structure

In Indio Police Command Unit Association, et al., v. City of Indio, et al. (--- Cal.Rptr.3d ---, Cal.App. 4th Dist. September 15, 2014) a California Court of Appeal confirmed the applicability of Meyers-Milias-Brown Act...more

Immigration Law Does Not Preempt State Wage and Hour Claims, Says Court

In case there was any question, an Indiana staffing company, Access Therapies, learned late last month that the Immigration and Nationality Act (INA) does not absolve employers of their responsibilities under state wage and...more

MARAD Issues Proposed Policy on Oil and Gas Exports from Offshore Facilities

On Oct. 16, 2014, the Maritime Administration (MARAD) issued a notice in the Federal Register seeking public comments on proposed policies regarding the review and processing of applications for the export of oil and natural...more

Should the Insurance Commissioner Actually Read the Policy Forms Submitted for Approval?

Dave Jones identifies himself to voters as an activist Insurance Commissioner who champions the insurance consumers’ rights. This is the guy who took on the insurance industry practice of side arbitration agreements in...more

Alberta Privacy Law Update: PIPA on Death’s Door

About a year ago on November 15, 2013, Alberta’s Personal Information Protection Act (PIPA) was declared invalid on constitutional grounds. The Supreme Court of Canada (SCC), in its wisdom, deferred the effect of this order...more

Status of Canadian Resource Revenue Transparency Reporting

In June 2013, Prime Minister Harper announced that within two years the federal government would establish mandatory reporting standards for Canadian extractive companies to enhance transparency on the payments they make to...more

Illinois Supreme Court Seems Likely to Reinstate Attorney General's Appeal from ICC Order

In the recently concluded September term, the Illinois Supreme Court heard one of the shortest civil arguments it has heard in many years in People ex rel. Madigan v. Illinois Commerce Commission. Madigan seems likely to...more

To Campaign or Not to Campaign: A Refresher

As November elections and some major ballot measures loom, and as 2016 general election candidates start copping to “thinking about a run,” now seems a good time to revisit the impartiality required of public agencies and...more

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