News & Analysis as of

Comment Period Investigations

Ropes & Gray LLP

Clinical Trial Protocol Deviations: A New FDA Draft Guidance to Ring in the New Year

Ropes & Gray LLP on

As the curtain closed on 2024, FDA issued a new draft guidance to assist clinical trial sponsors, investigators, and institutional review boards (“IRBs”) with defining, identifying, and reporting protocol deviations in...more

Axinn, Veltrop & Harkrider LLP

Countdown to Deadline for Comment Submission to the ITC

Five days remain to submit comments to the ITC's Proposed Amendments to the Rules of Practice and Procedure for Section 337 investigations: https://www.regulations.gov/, Docket No. MISC-049. The proposed rule changes include:...more

BCLP

Response to FCA's CP24/2

BCLP on

We strongly disagree with the FCA’s proposals, set out in CP24/2, to announce that it has opened enforcement investigations into firms where it considers this to be in the public interest. We set out our objections in detail...more

Torres Trade Law, PLLC

U.S. Trade Representative Initiates Section 301 Investigation of China’s Attempts to Dominate Maritime Industries

Torres Trade Law, PLLC on

On April 17, 2024, the United States Trade Representative (“USTR”) initiated an investigation pursuant to Section 301 of the Trade Act of 1974 (“Section 301”) regarding China’s acts, policies, and practices to dominate the...more

McDermott Will & Emery

International Trade Commission Seeks Feedback on Proposed Updates to Practice and Procedure

McDermott Will & Emery on

The US International Trade Commission issued a Federal Register notice of proposed rulemaking related to 19 C.F.R. Parts 201, 205, 207 and 210, which govern the Commission’s Rules of Practice and Procedure. The Commission...more

Health Care Compliance Association (HCCA)

Bucking History, ORI Deputy Denies Requests For Misconduct NPRM Comment Extension

Report on Research Compliance 20, no. 12  (December 2023) In a move that is unprecedented in recent memory, a federal agency has denied a request to extend the comment period on a substantive proposed rule, turning down a...more

Holland & Knight LLP

FDA, PFAS and Food Packaging: More to Come?

Holland & Knight LLP on

The U.S. Environmental Protection Agency (EPA) is not the only federal agency that regulates per- and polyfluoroalkyl substances (PFAS). And states aren't the only ones scrutinizing PFAS in food packaging products. PFAS,...more

McDermott Will & Emery

An Analysis of the Auxin Petition and Commerce Investigation and Their Impact on the Solar Industry

McDermott Will & Emery on

On February 8, 2022, Auxin Solar Inc. filed a petition requesting that the US Department of Commerce (Commerce) initiate a circumvention investigation into whether imports of crystalline silicon photovoltaic cells (CSPs)...more

Sheppard Mullin Richter & Hampton LLP

FDA Releases Guidance for Digital Health Tech Used in Clinical Investigations

n December 22, 2021, the Food and Drug Administration (FDA) issued a draft guidance for sponsors, investigators, and other interested parties on using digital health technologies (DHT) to acquire data remotely from...more

Jones Day

U.S. to Review and Consider Additional Section 301 Tariffs Targeting the EU Over Trade Dispute

Jones Day on

The Situation: The U.S. government is revisiting whether to maintain or impose up to 100% additional tariffs on certain goods originating in the European Union following the World Trade Organization's ("WTO") recent findings...more

WilmerHale

USTR Launches Section 301 Probe of France's Digital Services Tax

WilmerHale on

The Office of the U.S. Trade Representative (“USTR”) announced on July 10 the initiation of an investigation under Section 301 of the Trade Act of 1974 into France’s digital services tax (“DST”). The French Senate...more

Akin Gump Strauss Hauer & Feld LLP

Red Notice Newsletter - September 2018

ANTICORRUPTION DEVELOPMENTS - Petrobras Settles with U.S. Authorities Over Alleged FCPA Violations - On September 27, 2018, the U.S. Department of Justice (DOJ) and the Securities and Exchange Commission (SEC)...more

Miller Canfield

Department of Education Rescinds Obama Era Guidance on Sexual Harassment & Provides Interim Rules

Miller Canfield on

The U.S. Department of Education Office of Civil Rights ("OCR") this morning formally rescinded its April 4, 2011, Dear Colleague Letter as well as the April 29, 2014, Questions and Answers on Title IX and Sexual Violence....more

Ogletree, Deakins, Nash, Smoak & Stewart,...

The Department of Education Withdraws Obama-Era Title IX Guidance, Issues Interim Q&A

On Friday, September 22, 2017, when the Trump administration announced that it was rescinding Obama-era Title IX sexual assault guidance and issuing a new question and answer document while undertaking a formal review, most...more

Polsinelli

Proposed Rule to Strengthen State Medicaid Fraud Control Units

Polsinelli on

A recently published proposed rule expands the functions and responsibilities of state Medicaid Fraud Control Units (MFCUs). The rule was issued by the Centers for Medicare and Medicaid Services (CMS) and the Office of...more

Conn Maciel Carey LLP

EPA Poised To Make Sweeping Changes to the Risk Management Program Rule

Conn Maciel Carey LLP on

Chemical manufacturers and petroleum refiners are closely tracking the latest activities of a high-level agency working group formed pursuant to President Obama’s Executive Order (13,650) responding to the West, Texas,...more

King & Spalding

ITC Section 337 Update – October 2015

King & Spalding on

ITC Proposes Extensive Changes To Rules For Adjudicating Section 337 Investigations – On September 24, 2015, the Commission published a Notice of Proposed Rulemaking in the Federal Register announcing proposed changes to its...more

17 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