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Regulatory Standards

eCTD Format Required for all Mutual Recognition Procedure Submissions

by Hogan Lovells on

Despite earlier recommendations to the contrary, as of 1 January 2018 all types of EU mutual recognition procedure (“MRP”) submissions should be made in electronic Common Technical Document format (“eCTD format”)....more

Advances in Polish IP Law, part 2: Trademarks – graphic representation, renewal, partial transfer & enforcement by licensees

by Hogan Lovells on

The recently published draft of the Act amending the Industrial Property Law (14 November 2017) introduces fundamental changes in the provisions on trademark protection. Currently, the bill is being agreed upon in the Council...more

MHRA confirms UK stance in Brexit update to pharma industry

by Hogan Lovells on

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has published an update to pharmaceutical companies in the UK on the status of the Brexit negotiations and confirmed the UK's wish for there to be a transition...more

ACCC Increases Enforcement of Consumer Guarantees Against Airlines

by Jones Day on

The Situation: Following consumer complaints, the Australian Competition and Consumer Regulator ("ACCC") has released a report reminding airlines of obligations when dealing with the flying public. Looking Ahead: The ACCC...more

No More Delays! New Disability Claims Rules to Take Effect April 2, Says DOL

On April 2, 2018, significant changes to ERISA’s disability claims procedures will take effect. These new rules will require all ERISA-covered plans which provide disability benefits to make significant modifications to the...more

Advances in Polish IP law, part 1: Patents – Indirect infringement, limitation of scope & state of the art searches

by Hogan Lovells on

The bill amending the Industrial Property Law, published on 14 November 2017, introduces important changes with respect to patent protection. The bill adapts the Polish provisions to the European Patent Convention, as well as...more

Website Accessibility Cases Proceed Despite Absence of Regulations

by Akerman LLP - HR Defense on

Recent trends indicate that ’tis always the season for web accessibility litigation, so with the new year, you should take a new look at your website. Businesses around the country, and especially in Florida, are discovering...more

Interior Department Excludes Incidental Take Liability Under the Migratory Bird Treaty Act

by Latham & Watkins LLP on

Reversing a long-standing federal legal position, the US Interior Department recently stated that the Migratory Bird Treaty Act (MBTA) does not impose liability for the incidental take of protected birds. The 41-page...more

AHCA Sees the Light on Nursing Home Generator Rule, Unplugging Challenge

After Hurricane Irma made landfall in Florida, a nursing home in South Florida lost power, and several residents of that nursing home died allegedly as the result of increased temperatures caused by the loss of air...more

DOT v. FAA: Oversight of regional Air Carriers

by LeClairRyan on

A just-released report by the U.S. Department of Transportation (DOT) Office of Inspector General (OIG) points to the importance of the regional airline industry in safely transporting passengers, economic changes buffeting...more

Financial Markets Disputes and Regulatory Update - January 2018 - What can we learn from the second half of 2017

by Dentons on

Court decisions/impacts - Cases which consider the construction and use of standard form financial agreements almost always deserve reading. Most notable in this category is the judgment of the Court of Appeal in Dexia v....more

Canada 2018 Cannabis Regulation - Provincial Update

by Bennett Jones LLP on

As the July 2018 date of legalization approaches, Canadian provinces continue to announce their plans for the regulation, distribution and sale of recreational cannabis. These announcements are a response to the federal...more

SEC Committee Advocates for Summary Mutual Fund Shareholder Reports

by Carlton Fields on

On December 7, the Investor Advisory Committee of the Securities and Exchange Commission (SEC) adopted a recommendation that the SEC seriously explore the development of a summary disclosure document for mutual fund companies...more

FCC Proposes Excluding Twilight Towers from Historic Preservation Review

by Hogan Lovells on

The FCC has proposed to exclude so-called “Twilight Towers” from routine historic preservation review under Section 106 of the National Historic Preservation Act (“NHPA”) and its regulations.  Twilight Towers are towers that...more

Trump and the Oil Patch One Year In

by Gray Reed & McGraw on

Let’s take a look at what President Trump has done for the oil industry in his first year (This is not about decorum, dossiers, tweets, or Oprah’s inauguration.) As in the past I refer to sources whose opinions and insights...more

Preparing for New York Regulation 210’s Effective Date

by Carlton Fields on

The Preamble to New York’s Regulation 210 (the "Regulation") contains a March 19, 2018 effective date. However, the Regulation’s scope paragraph supports an interpretation that the Regulation’s requirements apply only when an...more

Food & Beverage Litigation Update | January 2018

FDA Announces Intent Not to Enforce Portions of FSMA - The U.S. Food and Drug Administration (FDA) has announced it will not enforce certain provisions of the Food Safety Modernization Act (FSMA) because the agency needs...more

Drones May Improve Safety and Efficiency for U.S. Airport Operations

While it may seem counter-intuitive, airports might just be one of the safest places for drones to fly; that is, with the caveat that drone flight in the unregulated airspace around the airports is clearly not safe and not...more

EPA Adjusts For Inflation The Maximum Civil Penalties For Violations Of Environmental Statutes

by Seyfarth Shaw LLP on

Seyfarth Synopsis: EPA has promulgated its new per violation penalty rules for 2018. The U.S. Environmental Protection Agency (EPA) has again issued final regulations adjusting the maximum civil penalty dollar amounts for...more

Rulings, Orders, Settlements – January 10, 2018

by Perkins Coie on

Court Grants Motion to Dismiss Class Action Involving Organic Baby Formula - Organic Consumers Association v. The Hain Celestial Group, Inc., No. 1:16-cv-00925 (D.D.C.): The Court entered an order granting Defendant’s...more

No Fooling: U.S. Department of Labor Confirms That The Disability Claims Regulations Will Go Into Effect on April 1, 2018 Without...

In a recent news release, the Employee Benefits Security Administration (EBSA) of the U.S. Department of Labor confirmed that its final rule amending the disability claims procedure requirements applicable to ERISA-covered...more

IVASS provides instructions to insurance intermediaries for preventing cyber risks

by Hogan Lovells on

IVASS has just published a letter to the market addressed to Italian and EU insurance intermediaries and undertakings addressing the level of awareness of traditional intermediaries about the risks involved in the use of new...more

Your Daily Dose of Financial News

by Robins Kaplan LLP on

The Times explores the $27 billion in fixed-income-trading income that has seeped out of Wall Street over the past 5 years thanks to “a combination of tough regulations, new technologies, calm markets and changing customer...more

Final Rule Clarifies When Substance Abuse Programs Can Disclose Patient Information

by Pepper Hamilton LLP on

A final rule from the Substance Abuse and Mental Health Services Administration establishes requirements for the exchange of patient information between substance abuse treatment programs and their agents and contractors. ...more

Pennsylvania Adds Licensing Requirements for Mortgage Servicers

by Ballard Spahr LLP on

Pennsylvania is adding a requirement that a Mortgage Servicer License is required to engage in the mortgage loan business as a mortgage servicer. As such, the definition of “mortgage loan business” has been amended to include...more

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