Election Roundup: How a Harris Administration Could Shape the Oil and Gas Landscape
4 Key Takeaways | Solar Industry & Chinese Tariff Update
The Labor Law Insider: (Scary) Real Life Scenarios – Practical Application, Part I
New Wave of Pay Transparency Requirements Affects Employers and Federal Contractors
The Biden Administration's Push for Transparency in AI Technology
Successor Government Contractor Hiring Obligations Change: DOL’s Long Awaited Nondisplacement Rule
Protecting Our Nation’s Data: Cybersecurity Compliance for Government Contractors
AI Around the Globe: What to Know in 2024
Video: Making Trade Inclusive for All Americans: A Conversation with AAEI's Eugene Laney Jr., Ph.D.
Podcast - The FTC Agenda & Data Privacy
Consumer Finance Monitor Podcast Episode: What the Biden Administration’s “Junk Fees” Initiative Means for the Consumer Financial Services Industry: A Look at the Fees Under Attack, Part II
The Labor Law Insider: Recent U.S. Supreme Court, NLRB Decisions Highlight Labor Issues in Higher Education
Consumer Finance Monitor Podcast Episode: What the Biden Administration’s “Junk Fees” Initiative Means for the Consumer Financial Services Industry: A Look at the Fees Under Attack, Part I
Consumer Finance Monitor Podcast Episode: The U.S. Supreme Court’s Decision Invalidating the Biden Administration’s Student Loan Forgiveness Plan and its Potential Legal Repercussions
Consumer Finance Monitor Podcast Episode: A Close Look at the Impact of Antitrust Laws on the Consumer Financial Services Industry
DE Under 3: President Biden Issued "Modernizing Regulatory Review" Executive Order
Business Better Podcast Episode: An Update on Environmental Justice Under the Biden Administration
#WorkforceWednesday: FTC Proposes Ban on Non-Competes - Employment Law This Week® - Spilling Secrets Podcast
Compliance into the Weeds - ChatGPT for the Compliance Professional
Navigating the FTC’s Proposed Rule Banning Non-Competes
On May 14, 2024, the Biden administration announced expansions to the United States’ Section 301 tariffs on imports from China, proposing to raise tariffs on solar panels, electric vehicles, batteries, green energy supply...more
As the life sciences, medtech, and diagnostic industries continue to expand and grow increasingly complex, so does the legal, regulatory, and compliance landscape. To help companies and investors navigate the many evolving...more
It’s no secret that Democrats are traditionally trustbusters, but the Biden Administration is taking things to a whole new level, bringing novel—and arguably weak—cases that nonetheless slow or block tie-ups among healthcare...more
The Food and Drug Administration (“FDA” or “agency”) intends to issue a notice of proposed rulemaking in August 2023 that will “make explicit” that laboratory developed tests (LDTs) are devices under the federal Food, Drug,...more
Since the beginning of the COVID-19 pandemic, the US Food and Drug Administration (FDA or the Agency) has issued more than 80 guidance documents describing flexibilities that would be available to manufacturers of medical...more
On January 30, 2023, the Biden administration announced its intent to end the national emergency and public health emergency (PHE) declarations on May 11, 2023. These emergency declarations have been in place since early...more
On January 4, 2023, the Biden Administration belatedly released the Fall 2022 Unified Agenda of Regulatory and Deregulatory Actions (the Unified Agenda). Typically published twice a year in the spring and the fall by the...more
Is it time for a glimmer of optimism about reducing at least one unacceptably high health care cost? Say hear, hear then, to the federal Food and Drug Administration’s removing the last regulatory block to...more
This issue of McDermott’s Healthcare Regulatory Check-Up highlights notable enforcement activity between April 21 and May 20, 2022, including a telemedicine case involving $64 million in false and fraudulent claims. We also...more
Last week, in the midst of the Biden Administration’s coordinated release of more than 90 “Equity Action Plans” by various federal agencies, the FDA issued a new draft guidance on enhancing clinical trial diversity. In a...more
We are just one quarter into 2022 and the Food and Drug Administration (FDA) already has experienced a number of significant changes and developments. A new commissioner has been confirmed (Robert Califf, M.D., who previously...more
In this week’s issue, OSHA withdrew its emergency temporary standard (ETS), which required a mandatory vaccination policy for large private employers with an exception for employers that adopt a policy requiring mandatory...more
Last week, Diana DeGette (D-CO) and Fred Upton (R-MI) introduced in the House highly anticipated bill language for “Cures 2.0”, a follow-up to the transformational 21st Century Cures Act enacted in 2016... The 21st Century...more
In the past week, the FDA granted an EUA for the Pfizer-BioNTech vaccine for use in children 5–11 years of age. The agency also participated in the launch of the Bespoke Gene Therapy Consortium. The Administration held a...more
Last week, the White House COVID-19 Response Team encouraged school systems to implement a layered approach to prevention as schools return to in-person learning. Moderna submitted a Biologics License Application (BLA) for...more
The Biden Administration has taken (at least temporarily) the teeth out of a Trump-era Executive Order that directed the government to “Buy American” for essential drugs and medical devices. President Trump’s August 2020...more
In a not-so-unexpected turn of events, the Biden-Harris administration’s Department of Health and Human Services (HHS) and the US Food and Drug Administration (FDA) rescinded a notice issued by the Trump administration’s HHS...more
Biden Administration Delays Effective Date and Opens Another Comment Period for New Medicare Coverage Pathway for Breakthrough Medical Devices and Definition of “Reasonable and Necessary” - To the dismay of the medical...more
In the past week, President Biden signed the American Rescue Plan, which provides $10 billion to expand domestic production of medical supplies. The President also announced that all adults in the U.S. will be eligible for...more
In Washington: On Feb. 23, officials from five major vaccine companies will be testifying before the House Energy and Commerce Subcommittee on Oversight and Investigation. Chairperson Diana Degette (D-CO) will be holding a...more
At the beginning of February, the US Food and Drug Administration (FDA) Center for Devices and Radiological Health (CDRH) appointed Professor Kevin Fu as the first ever Acting Director of Medical Device Cybersecurity. Fu’s...more
In one of the last proposed notices from the US Department of Health and Human Services (HHS) under the Trump administration, HHS removed the 510(k) premarket notification requirement for seven types of gloves and proposed...more
Considering the tight timeline for preparing responses to FDA compliance actions coupled with the agency’s expectation for timely implementation of corrective and preventive actions, the benefit of obtaining feedback through...more
Medical device companies should be prepared for an increase in FDA enforcement activity with the incoming Biden administration, in addition to changes in agency leadership and repeals of regulatory reform....more
How will the election affect life sciences in 2021 and beyond? What’s ahead for the regulatory and policy environment? In this session, our elite group of policy analysts reviewed the election results and the far-reaching...more