- House Oversight Committee Holds Its First ESG Hearing – An Overview for Asset Managers (May 26, 2023)
- Supreme Court Affirms Federal Circuit’s Amgen Decision: Patent Specification Must Enable the Full Scope of the Invention (May 22, 2023)
- FDA Guidance Clarifies Approach to Decentralized Clinical Trials (May 5, 2023)
- Getting Smarter: FDA Publishes Draft Guidance on Predetermined Change Control Plans for Artificial Intelligence/Machine Learning (AI/ML) Devices (May 2, 2023)
- HHS Proposes Changes to the HIPAA Privacy Rule to Strengthen Privacy Protections for Reproductive Health Care Information (April 25, 2023)
- Ropes & Gray’s Investment Management Update February – March 2023 (April 12, 2023)
- DOJ’s Withdrawal of Policy Statements Relating to Antitrust Enforcement in Healthcare Markets (April 6, 2023)
- Justice Department Announces New Policies Impacting Corporate Criminal Enforcement (March 7, 2023)
- U.S. Life Sciences Outlook 2023 (Part IV): Additional Insights on Expected Developments (March 1, 2023)
- U.S. Life Sciences Outlook 2023 (Part II): Anticipated Agency Policy Developments (February 23, 2023)
- Russia/Ukraine Crisis: U.S. Announces New Tranche of Sanctions and Export Controls (February 27, 2023)
- Private Fund Regulatory Update: Recent Developments Regarding the Marketing Rule FAQ, SEC’s Rulemaking Agenda and 2023 Exam Priorities (February 22, 2023)
- The U.S. Government Accountability Office Recommends Actions to Improve Federal Oversight of Institutional Review Boards for Human Research (February 17, 2023)
- Department of Labor’s ESG Rule Attacked on Multiple Fronts (February 9, 2023)
- The End of an Era: How Will Terminating the COVID-19 Public Health Emergency Affect Life Sciences Companies? (February 8, 2023)
- FTC Announces New HSR Filing Fees Of Up to $2.25 Million and Revised HSR Thresholds for 2023 (January 25, 2023)
- DOJ Unveils Changes to the Criminal Division’s Corporate Enforcement Policy to Incentivize Voluntary Self-Disclosure and Cooperation (January 20, 2023)
- The Centers for Medicare & Medicaid Services Proposes Changes to the Medicare Advantage and Medicare Part D Programs (January 18, 2023)
- Consumer Products in Focus: New FTC and FDA Guidances Address the Marketing of Health Products (January 10, 2023)
- New FDA Reform Legislation: Congress Gifts a “FDORA” for the Holidays (January 9, 2023)
- Congress Enacts Legislation Requiring Guidance on Clinical Research Diversity and Modernization (January 9, 2023)
- IRS Guidance Answers Certain Questions for SPACs on Applicability of Excise Tax, but Some Uncertainty Remains (January 5, 2023)
- Ropes & Gray’s Investment Management Update October – November 2022 (December 13, 2022)
- Podcast - Non-binding Guidance: The Regulatory Landscape for Drug Compounding—10 Years After the NECC Outbreak (December 5, 2022)
- Climate-related Disclosures and Targets Proposed for U.S. Federal Government Contractors – An Overview (November 30, 2022)
- Podcast - Talkin' Trade: Examining the Interplay Between the ITC and District Courts (November 29, 2022)
- DOL Final Rule Embraces Principles-Based Approach to ESG Factors in Investments and Proxy Voting – Initial Reactions (November 23, 2022)
- Podcast - Non-binding Guidance: Key Takeaways from FDA’s Final Guidance on Clinical Decision Support Software (November 21, 2022)
- Medicare Rules: Promoting Competition? (November 15, 2022)
- Introducing Navigating State Regulation of ESG Investments (November 7, 2022)
- SEC Staff Issues FAQ Regarding Investment Adviser Consideration of DEI Factors (October 17, 2022)
- White House Issues Executive Order Outlining Key Points of the Transatlantic Data Privacy Framework (October 13, 2022)
- Is Your Clinical Decision Support Software a Medical Device? Final Guidance Details FDA’s Latest Thinking (October 3, 2022)
- New Executive Order Formalizes Expanded CFIUS Purview (September 20, 2022)
- Harmonizing the Common Rule and U.S. Food and Drug Administration Human Subjects Research Regulations (September 13, 2022)
- CFTC Staff Further Extends No-Action Relief from Certain Position Aggregation Requirements (August 19, 2022)
- House Passes Inflation Reduction Act, Including Corporate Minimum and Excise Taxes (August 12, 2022)
- Congress Paves the Way for Drug Pricing Reforms with Passage of the Inflation Reduction Act of 2022 (August 12, 2022)
- Proposed Senate Legislation Would Limit Capital Gain Treatment for Carried Interests (August 3, 2022)
- Lummis-Gillibrand Digital Asset Bill – Key Takeaways (June 17, 2022)
- Russia/Ukraine Crisis: U.S. Sanctions Escalation Continues (May 9, 2022)
- Russia/Ukraine Crisis: U.S. Imposes Significant New Sanctions in Response to Russian Atrocities in Ukraine (April 8, 2022)
- Podcast - Talkin' Trade: Enforcement of Section 337 Exclusion Orders at U.S. Customs and Border Protection (April 7, 2022)
- Podcast - Non-binding Guidance: Real-World Evidence in Drug Development (March 30, 2022)
- Russia/Ukraine Crisis: OFAC Announces Hundreds of New Sanctions Designations (March 24, 2022)
- Expansive Federal Breach Reporting Requirement Becomes Law (March 22, 2022)
- SEC Issues Proposed Rules on Public Company Cybersecurity Disclosures (March 16, 2022)
- Cryptocurrency and 401(k) Plans: DOL Implores Fiduciaries to Exercise Extreme Care (March 15, 2022)
- Russia/Ukraine Crisis: Latest Round of U.S. Sanctions (March 14, 2022)
- SEC Proposes New Reporting Regime for Short Sales (March 10, 2022)
- U.S. Executive Order on the Development of Digital Assets (March 10, 2022)
- FDA Proposed Rule Would Harmonize U.S. Quality System Requirements for Medical Devices with International Standard (March 8, 2022)
- Russia/Ukraine Crisis: Additional International Sanctions Response (February 28, 2022)
- Russia/Ukraine Crisis: New Tranches of U.S. Sanctions and Export Controls (February 28, 2022)
- Podcast: Talkin' Trade: The Powerful General Exclusion Order (February 23, 2022)
- Russia/Ukraine Crisis: The Evolving International Sanctions Response (February 23, 2022)
- Bipartisan Slave-Free Business Certification Act Reintroduced in the U.S. Senate (February 22, 2022)
- SEC Proposes Cybersecurity Risk Management Rules for Registered Funds and Advisers (February 18, 2022)
- SEC Proposes Substantial Changes to Beneficial Ownership Reporting (February 17, 2022)
- U.S. Senator Requests Study on Potential Unified United States Intellectual Property Office (February 3, 2022)
- DOJ Increases Focus on Clinical Trial Fraud (February 1, 2022)
- 2021 Enforcement Review: FDA-Regulated Medical Products (January 31, 2022)
- FTC Announces 2022 Revised Jurisdictional and Filing Fee Thresholds (January 24, 2022)
- January Private Client Update (January 24, 2022)
- Podcast: Private Fund Regulatory Update: Recent Developments Regarding Management Fee Calculation and Electronic Communications (January 24, 2022)
- Podcast: How Would an ESG-Friendly DOL Final Rule Change the Investment Marketplace for ERISA Plans? (January 18, 2022)
- Contemplating a Post-COVID Return to “Normal Operations”: FDA’s Transition Plans for Devices Marketed Under Emergency Use Authorizations and Enforcement Policies (January 13, 2022)
- SEC Proposes Money Market Funds Reforms (January 10, 2022)
- Podcast: Non-binding Guidance: Recent Developments in FDA Inspection Policy and Implications for Drug and Device Manufacturers (January 6, 2022)
- Private Fund Cybersecurity Requirements Changing Significantly in 2022 (January 5, 2022)
- Podcast: Talkin' Trade: What Remedies Can The International Trade Commission Impose? (January 5, 2022)
- A New Year for Drug Pricing and Price Reporting? What’s Happening Now and What’s New for 2022 (December 14, 2021)
- Ropes & Gray’s Investment Management Update October – November 2021 (December 13, 2021)
- United States Strategy on Countering Corruption (December 9, 2021)
- Disputing Tax Newsletter (December 8, 2021)
- Federal Agencies Issue New Draft Policy Statement Regarding Standard Essential Patent Licensing and Remedies, DOJ Seeks Public Comments (December 7, 2021)
- HHS Reverses Course on LDTs: COVID-19 LDTs Again Require FDA Premarket Review (December 3, 2021)
- Podcast: Talkin' Trade: Who’s Adjudicating Section 337 Investigations? (November 30, 2021)
- CMS Finalizes Repeal of Medicare “Breakthrough” Device Coverage Rule, Pledges to Invite Further Industry Input (November, 24, 2021)
- Podcast: The DOL’s About-face on ESG for ERISA Plan Fiduciary Investment Decision-making (November 22, 2021)
- Update: Nondebtor Release Legislation Approved by House Judiciary Committee (November 17, 2021)
- DOJ Civil Cyber-Fraud Initiative May Impact Health Care and Life Sciences Companies (November 10, 2021)
- Bipartisan Legislative Proposal Would Expand CFIUS’s Jurisdiction (November 10, 2021)
- Podcast: Non-binding Guidance: Rolling Back the Medicare Coverage of Innovative Technology (MCIT) Rule (November 8, 2021)
- ESG and Proxy Voting: The DOL’s About-Face on Trump-Era Regulations (October 18, 2021)
- Interim Final Rule Implements Controversial Surprise Billing Arbitration Provisions (October 14, 2021)
- Biden Administration Deems Some College Athletes Employees under the National Labor Relations Act (October 5, 2021)
- Budget Reconciliation Bill Sets the Stage for Estate Planning Overhaul (October 4, 2021)
- Podcast: Non-binding Guidance: FDA’s Intended Use Final Rule (September 21, 2021)
- Large IRAs and High-Income Retirement Savers Targeted by Amendment to Budget Reconciliation Bill (September 20, 2021)
- Representatives Schweikert and DelBene Reintroduce Bipartisan Advancing America’s Interests Act to Curtail Intellectual Property Enforcement at the International Trade Commission (September 9, 2021)
- Podcast: Talkin' Trade: The Interplay Between the ITC and the PTAB (September 1, 2021)
- Proposed Legislation Would Subject Carried Interests to Ordinary Income Treatment (August 16, 2021)
- Proposed Rule on CY 2022 Physician Fee Schedule Addresses Telehealth (Especially Mental Health), Drug Pricing and Reimbursement, Provider Enrollment, Vaccines, and Physician-Owned Distributor Transparency (August 13, 2021)
- Updated: Developments in Drug Pricing and Price Reporting as the Congressional Recess Approaches (August 2021) (August 11, 2021)
- Developments in Drug Pricing and Price Reporting as the Congressional Recess Approaches (August 2021) (August 3, 2021)
- Podcast: Non-binding Guidance: COVID-19 Vaccine Mandate Litigation (July 29, 2021)
- Podcast: The U.S. Supreme Court Agrees to Hear the Northwestern University Retirement Plan Fee Lawsuit (July 23, 2021)
- Podcast: Talkin’ Trade: IMPORTant Information! (July 22, 2021)
- FTC Proposals Could Significantly Expand Registered Funds’ Pre-Acquisition Notice Requirements Under the Hart-Scott-Rodino Act (July 19, 2021)
- 2021 | 2022 SEC Rules Impacting Registered Funds – Effective and Compliance Dates (June 25, 2021)
- Disputing Tax Newsletter, Spring Edition (June 23, 2021)
- Biden Administration Places Combatting Corruption at the Center of its National Security Agenda (June 14, 2021)
- Biden Administration Refines Chinese Military Companies Sanctions (June 4, 2021)
- Podcast: Non-binding Guidance: The Defense Production Act and the COVID-19 Pandemic (May 27, 2021)
- Podcast: Talkin' Trade: Introduction to Section 337 and the ITC (May 18, 2021)
- Podcast: Conductive Discussions: Cybersecurity Threats to the Chip Industry (May 10, 2021)
- American Family Plan—Summary of Certain Key Tax Components (April 30, 2021)
- New Laws Narrow the Scope of Market Exclusivity and Seek to Increase Awareness of Biosimilars (April 30, 2021)
- Podcast: Data, Privacy and Cybersecurity Under the Biden-Harris Administration (April 22, 2021)
- Podcast: Private Fund Regulatory Update: 2021 SEC Enforcement Priorities (April 14, 2021)
- PErspectives: Private Equity Industry Insights | Spring 2021 (April 9, 2021)
- Ropes & Gray’s Investment Management Update February – March 2021 (April 7, 2021)
- American Jobs Plan & Made in America Tax Plan—Summary of Certain Key Tax Components (April 2, 2021)
- American Rescue Plan Act (ARPA) Phase 5 Stimulus Package—Highlights of Certain Key Tax-Related Provisions in ARPA (March 26, 2021)
- Podcast: 2021 DOJ Enforcement Priorities Under U.S. Attorney General Merrick Garland (March 26, 2021)
- Key Employee Benefit Provisions of the American Rescue Plan Act of 2021 (March 19, 2021)
- Podcast: CMMI Program Delays and Suspensions—Recommended Next Steps (March 18, 2021)
- FCPA to Remain Enforcement Priority Under New Administration Against Backdrop of COVID-19 (March 18, 2021)
- Department of Justice Under Merrick Garland (March 17, 2021)
- Podcast: The Evolving Regulatory Landscape for ERISA Plan Fiduciaries—Cybersecurity Concerns for Plan Sponsors (March 16, 2021)
- Corporate Transparency Act Introduces New Reporting Requirements for Investment Funds and Advisers (March 12, 2021)
- Podcast: Non-binding Guidance: FDA Regulatory Developments in AI and Machine Learning (March 4, 2021)
- Amendment to D.C. False Claims Act Will Allow Tax Actions, Enhancing Tax Enforcement in the District (March 4, 2021)
- IRS and DOL Issue Separate COVID-19-Related Benefit Plan Guidance for Employee Benefit Plans and Plan Participants: Take Note of Opportunities and Deadlines (March 2, 2021)
- Chinese Government Introduces Rules Restricting Application of Foreign Laws (February 17, 2021)
- Back to the Future: New Executive Order Restarts Myanmar Sanctions (February 12, 2021)
- Podcast: Communist Chinese Military Companies Executive Order: Implications and Key Questions (February 11, 2021)
- President Biden’s Buy American Executive Order Signals Possible Heightened False Claims Act Risk for Government Contractors (February 11, 2021)
- IRS Issues Final Regulations on Deductions of Certain Settlement Payments to Governments (February 10, 2021)
- FDA Publishes Action Plan for Oversight of Artificial Intelligence/Machine Learning-Based Medical Software (February 9, 2021)
- Podcast: The Evolving Regulatory Landscape for ERISA Plan Fiduciaries—The Biden Administration & ESG and Proxy Voting Rules (February 9, 2021)
- FTC, DOJ Announce Suspension of HSR Early Termination (February 5, 2021)
- 2022 Medicare Advantage and Part D Final Rule Includes Update to Star Ratings System and Implementing Coverage and Transparency Measures (February 5, 2021)
- Ropes & Gray’s Investment Management Update December 2020–January 2021 (February 3, 2021)
- FTC Announces Revised Thresholds for Interlocking Directorates (February 2, 2021)
- Private Funds Report, Volume 1 – 2020 Year in Review And A Look Ahead (January 29, 2021)
- 2020 Enforcement Review: FDA-Regulated Medical Products and Food Safety (January 28, 2021)
- Bipartisan Proposal for Extension and Revision of Coronavirus Aid, Relief, and Economic Security Act (CARES Act) – Summary of Key Provisions (January 27, 2021)
- Medicare Expands Coverage of “Breakthrough” Medical Devices and Codifies “Reasonable and Necessary” Standard (January 21, 2021)
- Coronavirus Relief Legislation Creates Substantial Changes to Copyright and Trademark Law (December 28, 2020)
- Phase 4 Stimulus Package—Highlight of Certain Key Tax-Related Provisions in the Phase 4 Stimulus Package (December 22, 2020)
- A Review of 2020's Key U.S. Sanctions Developments (December 21, 2020)
- Outlook for Digital Assets May Improve in 2021 (December 18, 2020)
- ESG Legislation – Ten Bills for Public Companies to Watch in 2021 (December 10, 2020)
- The 2020 Election and Health Care (December 15, 2020)
- The 2020 Election and DOJ & SEC Enforcement Priorities (December 8, 2020)
- The 2020 Election and Life Sciences (December 1, 2020)
- The 2020 Election and Intellectual Property (November 24, 2020)