DE Under 3: FAR Council Seeks to Require Federal Contractors to Report First-Tier Subcontractor Information, Including Potentially Executive Compensation Data
DE Under 3: OMB Announced Finalized Overhaul to Federal Race & Ethnicity Data Collection Standards
DE Under 3: OFCCP Resurrects Proposal for Monthly CC-257 Employment Utilization Reports for Construction Contractors
DE Under 3: FAR Council Submitted for OMB Approval Proposed Rule on “Pay Equity and Transparency in Federal Contracting”
DE Under 3: Surprises Lurk Throughout OMB's 2023 Spring Regulatory Agenda
DE Under 3: OFCCP’s Controversial “Pre-Enforcement Notice & Conciliation Procedures” Final Rule Coming Soon
DE Under 3: President Biden Issued "Modernizing Regulatory Review" Executive Order
DE Under 3: OMB’s Initial Proposal to Overhaul Federal Race & Ethnicity Data Collections
DE Under 3: OMB Publishes Its Fall 2022 Regulatory Agenda
DE Under 3: Big Changes Coming to OFCCP's Supply & Service Contractor ICRs
DE Under 3: Employment Poster Requirements & the U.S. DOJ’s First-Ever Criminal Anti-Trust Prosecution
DE Under 3: Data Gathering & Data Delivery
DE Under 3: New Data Collection Burdens, NLRB’s Ruling Regarding Union Election Dismissals, and OMB’s Tech Modernization Fund
Biden’s Modernizing Regulatory Review – A New Paradigm?
DoD Cyber: A Conversation with Melissa Vice, COO for DoD’s Vulnerability Disclosure Program
Is it the End of the EB-5 World as We Know it? How to Prepare for Potential Changes
I-14: Update on EEO-1 and I-9 Forms, Employer Obligations After a Hurricane or Other Natural Disaster, and Attorney Jason Barsanti on Meal and Rest Breaks
The U.S. Senate and the U.S. House of Representatives are both considering legislation that could have a serious impact on the ability of U.S. biotechnology, drug, and medical device companies to do business with...more
Last week, McDermott+Consulting launched an election 2024 resource page, where you can find a 2024 health policy outlook and other insights into the November election. While regulations aren’t necessarily top-of-mind when...more
On July 25, 2023, the Centers for Medicare & Medicaid Services (CMS) republished its Drug Price Negotiation Process Information Collection Request (Negotiation Process ICR). The Negotiation Process ICR, which was originally...more
The U.S. Food and Drug Administration (FDA) announced a new pilot program on June 21, 2023 that gives sponsors of oncology products the opportunity to submit validation and performance data for laboratory developed tests...more
This Week in Washington: President Biden Signs Omnibus Appropriations Package into Law to Fund the Federal Government Through FY 2022...more
The United States Food and Drug Administration (FDA) for many years has been trying to increase the participation of minorities in clinical trials to help ensure that regulated products are tested and labeled in an...more
On July 9, 2021, President Biden enacted a sweeping executive order creating a “whole‑of-government competition policy.” Morrison & Foerster outlined the administration’s policy in a recent client alert that provides a...more
Report on Research Compliance 18, no. 7 (July 2021) - In a review of more than 500 NIH awards, the HHS Office of Inspector General (OIG) found that about one-fifth were funded “out of rank order,” and for more than a...more
PhRMA Suit Challenges Co-Pay/Accumulator Portion of December 2020 Medicaid Rule - On May 21, 2021, Pharmaceutical Research and Manufacturers of America (PhRMA) filed suit in the US District Court for the District of...more
In this episode of Triage, Andrew Ruskin and Victoria Hamscho provide an update on recent developments in the 340B Program and, in particular, on two recent legal challenges covered entities brought in response to drug...more
This week in Washington: The Continuing Resolution (CR) to fund the government until Dec. 11 was signed by President Trump; House passes COVID-19 stimulus bill....more
Report on Research Compliance 17, no. 9 (August 20, 2020) - The Office of Management and Budget has published guidance for agencies and recipients of federal awards and contracts, finalizing a document issued in February...more
On August 6, 2020, President Trump issued another Executive Order (“EO”) that will likely have dramatic and long-lasting effects on the pharmaceutical industry. The impact of the EO may be far greater than currently...more
On August 6, President Trump issued an Executive Order (EO) titled “Ensuring Essential Medicines, Medical Countermeasures and Critical Inputs Are Made in the United States.” The far-reaching EO seeks to ensure the domestic...more
This week in Washington: House passes first set of Appropriations bills; President Trump signs Executive Orders on Prescription Drugs after COVID-19 bill stalled....more
Out of a sample of 29 non-representative drug manufacturers surveyed earlier this year, 23 had publicly posted policies related to accessing their investigational drugs outside of the context of formal clinical trials,...more
Below is Alston & Bird’s Healthcare Week in Review, which provides a synopsis of the latest news in healthcare regulations, notices, and guidance; federal legislation and congressional committee action; reports, studies, and...more
Starting on 11 May 2019 there will be an additional layer of government review that may slow down the issuance of certain U.S. Food and Drug Administration (FDA) guidance documents. ...more
Congress - Hearings/Markups - Senate Finance Committee: "Drug Pricing in America: A Prescription for Change, Part III" - Tuesday, April 9, 2019: The Senate Finance Committee continued its drug pricing series by...more
Coming Week’s Highlights: Congress will continue to examine drug pricing; on Tuesday, the Senate Finance Committee will hold the third in a series of hearings, this one focused on pharmacy benefit managers (PBMs). The House...more
Upcoming Hearings - Tuesday, March 5, 2019 - Senate Committee on Health, Education, Labor and Pensions (HELP): “Vaccines Save Lives: What is Driving Preventable Disease Outbreaks?” - The Senate Committee on Health,...more
Upcoming Hearings - Tuesday, Feb. 26, 2019 - Senate Finance Committee: “Drug Pricing in America: A Prescription for Change, Part II” - The second hearing in a series on drug pricing in the Senate Finance Committee...more
Upcoming Hearings - Tuesday, Feb. 26, 2019 - Senate Finance Committee: “TBA Hearing on Drug Pricing” - The second hearing in a series on drug pricing in the Senate Finance Committee will include the testimonies of...more
Food/Dietary Supplements - FDA Issues Avocado and Hot Pepper Sampling Reports – The Food & Drug Administration (FDA) has made available two reports related to the sampling of avocados and hot peppers for the presence of...more
Following a truncated August recess, the House and the Senate returned to Washington after Labor Day with a full plate of legislative items to address prior to the end of the fiscal year on September 30. That list includes...more