News & Analysis as of

New Guidance Compliance Regulatory Requirements

Williams Mullen

PODCAST: Williams Mullen's Benefits Companion - Gag Clause Prohibitions

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On this episode of Williams Mullen's Benefits Companion, host Brydon DeWitt discusses prohibitive gag clauses under the Consolidated Appropriations Act (CAA). While intended to promote transparency, not all gag clauses are...more

Morrison & Foerster LLP

New Dietary Ingredient Notifications: FDA Addresses Common Pitfalls and Shares New 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

Akin Gump Strauss Hauer & Feld LLP

FDA Adds a Dose of Clarity to the NDIN Process

Recently, the U.S. Food and Drug Administration (FDA) released two educational videos and a supplemental fact sheet to guide dietary supplement manufacturers and distributors through the New Dietary Ingredient Notification...more

NAVEX

AI Literacy: A Compliance Need and a Training Necessity

NAVEX on

The European Union recently published guidance on the training that companies should provide to employees to achieve “AI literacy” required under the EU AI Act – and like so much else about artificial intelligence these days,...more

Jackson Lewis P.C.

New DOL/EBSA Opinion Letter Program Offers A Path to Clarity for Plan Sponsors

Jackson Lewis P.C. on

On June 2, 2025, the U.S. Department of Labor (DOL) announced a significant expansion of its compliance assistance tools by launching an Opinion Letter Program across five key enforcement agencies, including the Employee...more

Seyfarth Shaw LLP

“Dear DOL”: Labor Department Re-Launches Opinion Letter Program

Seyfarth Shaw LLP on

In a welcome development for employers navigating complex federal employment laws, the U.S. Department of Labor has announced the re-launch of its opinion letter program across several agencies, including the Wage and Hour...more

King & Spalding

FDA Issues Two Guidances For the Device Q-Sub Process

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CDRH and CBER Release Final Guidance for the Q-Submission Program and Draft Guidance for PreSTAR - On May 29, 2025, the U.S. Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) and Center...more

BakerHostetler

FDA Issues Draft Guidance on Replacing Color Additives in Drug Products

BakerHostetler on

On May 27, 2025, the Food and Drug Administration (FDA) released a new draft guidance, “Replacing Color Additives in Approved or Marketed Drug Products” (Guidance), that outlines regulatory expectations for manufacturers and...more

King & Spalding

CMS Issues New Guidance and Request for Information on Hospital Price Transparency Regulations

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Last week, CMS published new guidance and issued a Request for Information on the Hospital Price Transparency Rule in response to President Trump’s February 25, 2025 Executive Order titled, “Making America Healthy Again by...more

Jackson Lewis P.C.

Enforcing English Proficiency: Employers of Commercial Drivers Face New FMCSA Guidance

Jackson Lewis P.C. on

Businesses that employ drivers of commercial motor vehicles who operate in interstate commerce (CMV drivers) have some work to do before June 25, 2025. That is when CMV drivers who cannot speak and understand English...more

Akin Gump Strauss Hauer & Feld LLP

Restoring Gold Standard Science (Trump EO Tracker)

Orders the Director of the Office of Science and Technology Policy (OSTP Director) to issue guidance for agencies on implementation of “Gold Standard Science” in the conduct and management of their respective scientific...more

Venable LLP

Government Issues Nonenforcement Statement on Mental Health Parity Rules

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The government recently stated that it will delay enforcement of the 2024 final rules on the Mental Health Parity and Addiction Equity Act (MHPAEA). (Our previous alert regarding the 2024 final rules can be found here.) This...more

Alston & Bird

From Uncertainty to Action: DOJ Rolls Out a New White-Collar Enforcement Playbook

Alston & Bird on

Despite speculation that the Department of Justice Criminal Division might step back from white-collar criminal enforcement, newly announced DOJ Criminal Division policy updates indicate otherwise. Our White Collar,...more

Moore & Van Allen PLLC

The Desk: May Edition

On April 17, 2025, as previewed in the Division of Enforcement’s (“DoE”) February 25, 2025, “Advisory on Self-Reporting, Cooperation, and Remediation”, the Staff of the Market Participants Division (“MPD”) laid the remaining...more

McCarter & English Blog: Government Contracts...

The “Prestige”: DoD Unveils NIST SP 800-171 Revision 3, Organizationally Defined Parameters

On April 15, 2025, the Department of Defense (DoD) released official guidance on Organizationally Defined Parameters (ODPs) appearing in the newly published NIST SP 800-171 Revision 3. At the same time, the DoD reaffirmed...more

Davis Wright Tremaine LLP

CFTC Divisions Issue Staff Advisory on Referrals to Division of Enforcement

On April 17, 2025, the Market Participants Division, the Division of Clearing and Risk, and the Division of Market Oversight (collectively, the "Operating Divisions") of the CFTC, along with the Division of Enforcement...more

Davis Wright Tremaine LLP

DOJ Issues Guidance on Foreign Data Access Rule, Announces Conditional 90-Day Enforcement Pause for "Good Faith Efforts"

The Department of Justice (DOJ) has issued guidance on its recently effective rule targeting foreign adversaries that "use commercial activities to access, exploit, and weaponize U.S. Government-related data and Americans'...more

Mayer Brown

Department of Justice Releases Compliance & Enforcement Guidance on Data Security Program

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On April 11, 2025, the Department of Justice (DOJ) announced additional guidance regarding the implementation of the Final Rule (the “Rule”), Provisions Pertaining to Preventing Access to U.S. Sensitive Personal Data and...more

Lowenstein Sandler LLP

SEC Updates Guidance on the Use of Gross and Net Performance in Advertisements

Lowenstein Sandler LLP on

On March 19, the Securities and Exchange Commission (SEC) issued a new FAQ response1 that softens prior guidance on the use of gross and net performance in advertisements. The new FAQs (the New Guidance) reduce the burden of...more

King & Spalding

NY Department of Health Issues Clarifying FAQs on Healthcare Transaction Notice Law

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Earlier this month, the New York State Department of Health (DOH) released its first formal guidance under Public Health Law (PHL) Article 45-A, the state’s recently enacted healthcare transaction notice law. Issued in the...more

Flaster Greenberg PC

SEC Offers Updated Guidance for Rule 506(c) Private Placements

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On March 12, 2025, the SEC published a No-Action Letter clarifying accredited investor verification requirements under Rule 506(c)....more

Mayer Brown Free Writings + Perspectives

Staff Guidance on Non-WKSI Form S-3 Registration Process; Disclosure Requirements for Foreign Private Issuers

On March 20, 2025, the staff of the Division of Corporation Finance (the “Staff”) of the U.S. Securities and Exchange Commission (the “Commission”) made a number of changes to the Division’s Compliance and Disclosure...more

Rivkin Radler LLP

Quality of Care Considerations in OIG’s Nursing Facility Compliance Guidance

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In November 2024, the U.S. Department of Health and Human Services’ Office of the Inspector General (“OIG”) published the long-awaited Industry Segment-Specific Compliance Program Guidance for Nursing Facilities (“Nursing...more

Ropes & Gray LLP

New SEC Staff Guidance Allows Effectiveness of Non-Automatically Effective Form S-3s before Filing of Proxy Statement

Ropes & Gray LLP on

Form S-3 registration statements filed by issuers who are not well-known seasoned issuers may now be declared effective before the filing of the proxy statement containing Part III information that was properly omitted from...more

Tannenbaum Helpern Syracuse & Hirschtritt LLP

SEC Division of Investment Management Staff Revises Guidance on Certain Gross and Net Performance-Related Presentations

On March 19, 2025, the staff of the SEC’s Division of Investment Management (the “Staff”) updated its Marketing Compliance Frequently Asked Questions (“FAQs”) to address the inclusion by SEC-registered investment advisers of...more

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