News & Analysis as of

Regulatory Authority Compliance Regulatory Requirements

Dacheng

Decoding the Regulation of “Important Data” in China and the U.S.: Similarities and Differences, Compliance Obligations, and...

Dacheng on

With the rapid development of informatization, how to better safeguard national security in an increasingly complex information environment has become a critical consideration in digital legislation. A key issue within this...more

Mitchell, Williams, Selig, Gates & Woodyard,...

PCB Bulk Product Waste Storage Timeframes: U.S. Environmental Protection Agency Response to Region 1 Request for Approval of...

The United States Environmental Protection Agency (“EPA”) Office of Resource Conservation and Recovery issued a January 17th memorandum titled: Response to Region 1 Request Regarding PCB Bulk Product Waste Storage...more

Ward and Smith, P.A.

Attention North Carolina Retailers: Time to Renew Your ABC Permits!

Ward and Smith, P.A. on

If your business sells alcohol in North Carolina, now is the time to renew or register your Alcoholic Beverage Control (ABC) retail permit. Failure to complete this process on time could result in penalties, increased costs,...more

Mitchell, Williams, Selig, Gates & Woodyard,...

Use of Phosphogypsum/Small Scale Road Pilot Project: Center for Biological Diversity Files Federal Appellate Court Challenge to...

The Center for Biological Diversity (“CBD”) filed a Petition for Review (“Petition”) in the United States Court of Appeals for the Eleventh Circuit challenging the United States Environmental Protection Agency (“EPA”)...more

Mitchell, Williams, Selig, Gates & Woodyard,...

Transportation/Hazardous Materials: Pipeline and Hazardous Materials Safety Administration Letter Addressing Packaging Residue

The United States Pipeline and Hazardous Materials Safety Administration (“PHMSA”) addressed in a January 7th Interpretive Letter a question regarding the Hazardous Materials Regulation’s (“HMR”) applicability to residue on...more

Gardner Law

State Licensing Requirements: Are You Prepared?

Gardner Law on

Securing FDA clearance or approval is a major accomplishment for medical device and pharmaceutical companies, but it’s not the final step. Before selling your products in most states, you must navigate state licensing...more

Conyers

Recent Amendments to BVI Company Law: Key Changes

Conyers on

There have recently been a number of amendments to BVI company law. While many of these amendments are technical and will not have a material impact on clients, there are some key changes of which clients should be aware...more

Oliva Gibbs

No Risk, No Reward: The Liberty v. NDIC Decision Holds That Risk Penalties Can be Recovered From Total Unit Production

Oliva Gibbs on

In Liberty Petro. Corp. v. N.D. Indus. Comm’n, the Supreme Court of North Dakota addressed whether nonconsent risk penalties must be assessed on a well-by-well basis or can be recovered from overall unit production. The court...more

A&O Shearman

UK SRA’s new guidance on internal investigations and legal professional privilege

A&O Shearman on

Independence, legal privilege and reporting to internal stakeholders are key areas of focus in the UK Solicitor Regulation Authority’s (SRA) new guidance for in-house internal investigations lawyers published in November...more

Ballard Spahr LLP

CFPB issues compendium of bureau guidance issued between October 2021 and January 2025

Ballard Spahr LLP on

As the Biden Administration came to a close, the CFPB released a compendium of guidance documents issued by the bureau between October 2021 and January 2025....more

Latham & Watkins LLP

FDA Finalizes Guidance on Communications of Scientific Information on Unapproved Uses

Latham & Watkins LLP on

The final guidance describes FDA’s enforcement discretion policy for sharing scientific information on unapproved uses of approved products and suggests a safe harbor for sharing off-label information consistent with the...more

Goodell, DeVries, Leech & Dann, LLP

Understanding CMS “Immediate Jeopardy” Investigations in Healthcare Facilities

When it comes to ensuring patient safety, healthcare facilities operate under a complex regulatory framework, including oversight from the Centers for Medicare & Medicaid Services (CMS). One of the more intense processes CMS...more

Cooley LLP

Complete Response Letter, Warning Letter and Shareholder Lawsuit Follow FDA Data Integrity Findings

Cooley LLP on

Applied Therapeutics, a clinical-stage biopharmaceutical company, is under heightened scrutiny following the issuance of a November 2024 Warning Letter from the US Food and Drug Administration (FDA) on the heels of a routine...more

Davies Ward Phillips & Vineberg LLP

Changes to Québec’s Consumer Protection Regime: Monetary Administrative Penalties and Increased Penal Fines

Significant changes to the Québec consumer protection regime came into effect earlier this year. The president of the Office de la protection du consommateur (OPC), Québec’s consumer protection regulator, can now impose...more

Conyers

Responding to Regulatory Notices: A Litigator’s Perspective

Conyers on

There are a variety of information gathering and other compulsory notices available to regulatory and enforcement agencies based in the Cayman Islands, as tools these agencies can draw on to carry out their functions. In this...more

15 Results
 / 
View per page
Page: of 1

"My best business intelligence, in one easy email…"

Your first step to building a free, personalized, morning email brief covering pertinent authors and topics on JD Supra:
*By using the service, you signify your acceptance of JD Supra's Privacy Policy.
- hide
- hide