ML Strategies

You’d be forgiven in the current climate of coronavirus and election season, to name just a couple hot issues of the day, for missing two recent announcements from the FDA about its digital health program. On September 14, 2020, FDA published “Developing the Software Precertification Program: Summary of Learnings and Ongoing Activities” and the following week, on September 22, launched the Digital Health Center of Excellence.

Despite the COVID-19 pandemic, the House Energy & Commerce Committee continues work on several health policy issues, including Orphan Drug Act reform and continuous manufacturing.

Today, the Baker-Polito Administration’s Reopening Advisory Board published their report outlining a 4-phase schedule for reopening the Commonwealth since the closure of non-essential businesses on March 23.

This update covers federal and Massachusetts responses to the pandemic, including the House Democrats’ phase 4 economic stimulus proposal, the SBA’s report on PPP implementation plus criticism of how it manages EIDL, and Massachusetts’s reopening plan and its proposed $1B supplemental budget to cover Covid-19 spending.

This update covers federal and Massachusetts responses to the pandemic, including the U.S. Treasury Implementation of CARES Act programs, new proposals for small- and mid-sized businesses, the Paycheck Protection Program (PPP), and new Massachusetts rules related to masks, car dealers, and retailers.

On Monday, April 27, Representatives Diana DeGette (D-CO) and Fred Upton (R-MI) announced the next steps for 21st Century Cures 2.0 (Cures 2.0), legislation that will build on the original 21st Century Cures Act enacted in December 2016 (Cures 1.0). While Cures 1.0 aimed to speed up the process of bringing new treatments to market, Cures 2.0 is generally envisioned to emphasize public health and streamlined care delivery, particularly in light of the COVID-19 pandemic. Elements envisioned to be in Cures 2.0 were outlined in a recently published concept paper that we discuss in this post.

Responding to increased public and congressional criticism of its arguably too-flexible approach to regulatory oversight of serological tests used to detect COVID-19 antibodies, on May 4, 2020 the Food and Drug Administration (FDA) announced a revised policy aimed at reducing the risks associated with such tests.

This update covers federal and Massachusetts responses to the pandemic, including the Main Street Lending Program and the Municipal Liquidity Fund, Phase 4 stimulus provisions for disabled Americans, funding for Massachusetts nursing homes and congregate care, the state’s Reopening Advisory Board, and more.

This update discusses the new federal interim stimulus package, negotiations for the Phase 4 package, the Municipal Liquidity Facility, the SMART fund, plans to reopen the Massachusetts economy, and more.

Economists create graphs, charts and projections on the economy daily, crafting commentary to explain the ebbs and flows of market success and failures based on a variety of factors. That is no longer the case as the nation battles the novel coronavirus (“COVID-19”). Economist’s projections are at the mercy of the raging virus as many states enter “the surge”, compromising health care systems, learning institutions and local economies nationwide.

Read ML Strategies' analysis of federal and state legislative and regulatory responses to public health and economic issues related to the COVID-19 pandemic.

ML Strategies' analysis of federal and state legislative and regulatory responses to public health and economic issues related to the COVID-19 pandemic.