China’s NMPA Proposes Implementing Regulations for the Drug Administration Law
China’s National Medical Products Administration (“NMPA”) recently announced a comprehensive draft amendment (“Draft Amendment”) to the Implementation Regulation of ...
FDA Updates Guidance on Cybersecurity Responsibilities for Medical Device Manufacturers
On April 8, 2022, the U.S. Food and Drug Administration (“FDA”) released a draft guidance document titled “Cybersecurity in Medical Devices ...
CMS Issues Final Rule Redefining Medicare Part D “Negotiated Price” As Pharmacy’s Lowest Possible Reimbursement
On April 29, 2022, the Centers for Medicare & Medicaid Services (“CMS”) issued a final rule revising the way Medicare determines the ...
Mandatory Human Rights Due Diligence Legislation – Resources for Compliance
Over the last year, several jurisdictions have proposed or adopted mandatory human rights due diligence legislation that requires a more robust corporate response to human ...
Russia/Ukraine Crisis: U.S. Sanctions and Export Controls Escalation Continues
On May 8, 2022, the U.S. Department of the Treasury’s Office of Foreign Assets Control (“OFAC”) issued broad restrictions against ...
Conflict Minerals Compliance in 2022 – Resources for Compliance
Calendar 2021 U.S. Conflict Minerals Rule filings are due on May 31. Although the substantive requirements have not changed since last year, there are ...
OIG Finds Physician-Owned Medical Device Innovator Not a Suspect “POD”
The HHS Office of Inspector General (OIG) has released a favorable advisory opinion on physician ownership. The decision should be good news for some manufacturers ...
CMS Publishes Federal Fiscal Year 2023 Hospital Payment Proposed Rule
On April 18, 2022, the Centers for Medicare & Medicaid Services (“CMS”) published its annual proposed rule for the federal fiscal year ( ...
2022 Investment Management Conference
Click here to read the full Memorandum. Ropes & Gray’s memorandum summarizing the 2022 Investment Management Conference sponsored by the Investment Company Institute ...
Amendments to UCC on the Horizon Affecting Purchase and Sale of Digital Assets
In 2019, the Uniform Law Commission (“ULC”) and the American Law Institute (“ALI”) appointed a joint committee to review the Uniform ...
Pooled Employer Plans (“PEPs”): Putting a little PEP in a 401k retirement plan could help to protect your Portfolio Companies
Set against the backdrop of the continuing wave of ERISA litigation that is being brought against employers who sponsor retirement plans, Pooled Employer Plans ( ...
Latest Updates to UK and EU Sanctions
In response to Russia’s continued military invasion of Ukraine, both the United Kingdom and the European Union have implemented additional asset freeze and ...
Ten Thoughts on the SEC’s Proposed Climate Disclosure Rules
Last month, the Securities and Exchange Commission proposed long-awaited rules that would mandate enhanced climate-related disclosures by public companies. In this Alert, we ...
Ropes & Gray’s Investment Management Update February – March 2022
2022 ICI Investment Management Conference As we have in prior years, Ropes & Gray will soon distribute its summary of the speeches and panels at ...
Secondaries Sophistication Drives a Surge in Activity
Welcome to the April 2022 edition of PErspectives—our periodic publication featuring news, trends and legal developments in the private equity (PE) industry. In ...
Russia/Ukraine Crisis: U.S. Imposes Significant New Sanctions in Response to Russian Atrocities in Ukraine
On April 6-7, the Biden administration announced another set of sanctions and export restrictions targeting Russia in response to its ongoing invasion of ...
U.S. District Court of D.C. Invalidates Decision Denying Hospital Reimbursement for Indigent Bad Debt Based on Third-Party Information
On March 29, 2022, the U.S. District Court for the District of Columbia issued a favorable decision for the plaintiff hospitals in Sentara Hospitals ...
Latest Updates to UK and EU Sanctions Related to Russia and Belarus
This Alert summarizes actions taken in the United Kingdom and the European Union since our Alert dated March 16, published here. In particular, the United ...
China’s Ministry of Science and Technology Publishes Draft Rules on the Administration of Human Genetic Resources
China’s Ministry of Science and Technology (MOST) issued the Draft Implementing Rules on the Administrative Regulations on Human Genetic Resources for public comment ...
Russia/Ukraine Crisis: OFAC Announces Hundreds of New Sanctions Designations
On March 24, the Biden administration announced a fresh round of sanctions and other trade restrictions in response to Russia’s invasion of Ukraine ...
Expansive Federal Breach Reporting Requirement Becomes Law
On March 15, 2022, President Biden signed into law significant new federal data breach reporting legislation that could vastly expand data breach notice requirements far ...
Implementation of “Countering Foreign Influence Program” for Scientific Research Funded by DARPA
Over the past three years, the U.S. Congress has directed the Defense Advanced Research Projects Agency (“DARPA”), the research and development agency ...
Russia/Ukraine Crisis: The Latest UK/EU Sanctions Response
The United Kingdom and the European Union have continued to announce and implement new sanctions measures, accompanied by corresponding general licenses and updates to relevant ...
SEC Issues Proposed Rules on Public Company Cybersecurity Disclosures
On March 9, 2022, the Securities and Exchange Commission (“SEC”) proposed updates to its disclosure rules intended to “enhance and standardize ...
Cryptocurrency and 401(k) Plans: DOL Implores Fiduciaries to Exercise Extreme Care
On March 11, 2022, the U.S. Department of Labor (DOL) published Compliance Assistance Release No. 2022-01 (CAR 2022-01) in order to provide ...