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Looking Ahead: FDA in 2021
January 8, 2021 | Blog
Politics will have an effect on FDA policies in 2021, including with respect to the ongoing COVID-19 response, manufacturing, compliance, digital health, laboratories, user fees, device servicing, and more.
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FDA in 2020: What a Year!
December 15, 2020 | Blog | By Benjamin Zegarelli
What a year for the Food and Drug Administration! FDA, an agency with regulatory oversight of 20-25% of products on which consumers spend, including food and medicines, but which typically stays out of the limelight, was thrust into the public eye amidst the COVID-19 pandemic. This was the year many Americans became familiar with lesser-known and niche policies like those governing emergency use authorizations (EUAs) and with the role of FDA in regulating laboratory developed tests (LDTs). The agency also took some flak for seeming to bow to political pressure in authorizing hydroxychloroquine for emergency use as a potential COVID-19 treatment, then rescinding the authorization, as well as for its less-than-accurate pronouncements of positive data concerning convalescent plasma treatment. These were reminders that the agency Americans trust to protect the public does get things wrong sometimes and is susceptible in some ways to political pressure, and that effectively ensuring the public health requires a balance between safety and effectiveness and patient access to medical products. As we look ahead, we eagerly anticipate how FDA will protect and promote public health in a Biden administration. In this post we’ll explore the FDA’s device law and policy activities from 2020.
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ML Strategies Lame Duck Update: Trade and China Tariffs
December 8, 2020 | Blog | By R. Neal Martin
Massachusetts FY2021 Conference Report
December 7, 2020 | Blog | By Steven Baddour, Daniel Connelly, Caitlin Beresin, Kaitlyn Sprague, Taylor Shepherd
The fiscal year 2021 (“FY2021”) budget process has been anything but typical. Shortly after Governor Baker’s budget proposal was released in January, the COVID-19 pandemic struck, reorienting the legislative calendar for the remainder of the 2019-2020 legislative session.
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Post-Election 2020 - Health Care Preview
November 23, 2020 | Blog | By Alexander Hecht, Anthony DeMaio, Tara E. Dwyer
With the presidential transition underway, we now look forward to what the Biden administration will seek to accomplish, particularly in the realm of health care policy.
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Senate Passes IoT Cybersecurity Bill by Unanimous Consent
November 18, 2020 | Blog | By Christian Tamotsu Fjeld, Christopher Harvie
MLS Election Update: Impact on Trade
November 10, 2020 | Blog | By R. Neal Martin, Robert Kidwell, Alexander Hecht, Anthony DeMaio
Read about the post-election impact on international trade matters and the incoming administration's influence on the Committee on Foreign Investments in the U.S. (CFIUS).
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Massachusetts Congressional Delegation to the 117th Congress
November 10, 2020 | Blog | By Anthony DeMaio
Read about the Massachusetts congressional delegation to the 117th Congress, their current and potential committee assignments, and possible policy implications.
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MLS Election Update: Clean Tech, Energy & Environment
November 9, 2020 | Blog | By R. Neal Martin
Read about how the administration of President-Elect Joe Biden could shape clean tech, energy, and environmental policy in a divided government.
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Twitter, Facebook, Google Heads Testify on Section 230 and Local Journalism
October 29, 2020 | Blog | By Christian Tamotsu Fjeld, Christopher Harvie
FDA Provides Update on Pre-Cert Program and Launches Digital Health Center of Excellence
October 19, 2020 | Blog
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.
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Executive Compensation Practices in Pharma – Insight into Congressional Oversight
October 7, 2020 | Blog | By Alexander Hecht, Anthony DeMaio
Beyond COVID: House Committee Advances Several FDA-Related Bills
July 23, 2020 | Blog | By Margaret Jewett
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.
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Democrats Lay Groundwork for Infrastructure & Clean Energy Ahead of General Election
July 20, 2020 | Blog | By Thomas Burton, R. Neal Martin
Massachusetts’ Reopening Advisory Board Releases Reopening Report
May 18, 2020 | Blog | By Steven Baddour, Daniel Connelly, Kaitlyn Sprague, Caitlin Beresin, Taylor Shepherd
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.
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