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Regulatory Requirements Filing Requirements Regulatory Oversight

Morrison & Foerster LLP

New Dietary Ingredient Notifications: FDA Offers Clarification and Educational Tools

On June 11, 2025, the U.S. Food and Drug Administration (FDA) released educational videos and a new fact sheet to facilitate compliance with the agency’s New Dietary Ingredient Notification (NDIN) review process. Under the...more

Hogan Lovells

FDA finalizes 2025 Q-Submission Guidance, streamlining interactions for device sponsors and proposes electronic submission mandate...

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On May 29, 2025, the U.S. Food and Drug Administration (FDA) issued a final version of its guidance “Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program,” offering an expanded framework...more

Herbert Smith Freehills Kramer

Regulatory task force adopts asset adequacy testing for asset-intensive life reinsurance

U.S. life carriers engaging in “asset intensive reinsurance transactions” should consider new requirements for reporting and actuarial testing of these arrangements being developed by the National Association of Insurance...more

Ballard Spahr LLP

FinCEN Stresses Transparency, BSA Filing Data, and Perils of “Under- Regulating” to Securities Industry

Ballard Spahr LLP on

Last Thursday, FinCEN Deputy Director Jamal El-Hindi appeared at the 20th annual Anti-Money Laundering (AML) and Financial Crimes Conference hosted by the Securities Industry and Financial Markets Association (SIFMA) in New...more

Ballard Spahr LLP

Guilty Pleas Highlight Illicit Funneling of Chinese Cash to Casinos

Ballard Spahr LLP on

Government Suggests that Unusual Pleas are Just the Tip of an Iceberg - Chinese law generally prohibits its citizens from converting more than $50,000 in Chinese yuan into foreign currency in a year.  On Monday, two men...more

Skadden, Arps, Slate, Meagher & Flom LLP

CFIUS’ Final Rules: Broader Reach, Narrow Exceptions and Foretelling Future Change

On January 13, 2020, the U.S. Department of the Treasury (Treasury), on behalf of the Committee on Foreign Investment in the United States (CFIUS or the Committee), issued two sets of final regulations implementing the...more

Ballard Spahr LLP

SEC Reduces Filing Burdens On Investment And Operating Companies For Confidential But Not Material Information

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As part of its continuing effort to increase efficiency and reduce burdens on publicly traded companies, including registered investment companies, the U.S. Securities Exchange Commission (SEC) recently adopted amendments to...more

Carlton Fields

New Procedures for Mutual Fund and Insurance Product SEC Filings

Carlton Fields on

In Release No. 33-10618 (Mar. 20, 2019), the SEC adopted amendments (the “Amendments”) that consolidate, conform, and otherwise refine numerous requirements applicable to filings with the agency. ...more

Hogan Lovells

Patents - Patent litigation - Japan

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In Japan, the Intellectual Property High Court (IPHC) established in 2005 has jurisdiction to handle intellectual property cases as second instance, and registered IP cases appealed against trial decisions of the Japan Patent...more

Hogan Lovells

Complying with Mexican Labor Regulations

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The Internal Labor Regulations (ILR) is a set of mandatory rules for employees and employers for the development of work. Any policy applicable to employees should be included in the ILR to strengthen its enforceability....more

Carlton Fields

Expect Focus - Volume II, June 2018

Carlton Fields on

New York Pushes Mutual Fund Active Share Disclosure - New York’s Attorney General issued a report on its recent investigation of fees charged by actively managed equity mutual funds and a metric known as “Active Share.”...more

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