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Crunch Time for BIOSECURE Act
December 3, 2024|
Read about the BIOSECURE Act, its legislative path, and the broader context of critical end-of-year negotiations shaping the priorities of the 118th Congress.
PBM Policy and Legislative Update — Fall 2024
November 22, 2024|
Building upon prior issues and summarizing activity from July through September, the Fall 2024 PBM Update highlights federal legislative activity and oversight, state legislative activity and oversight, and other noteworthy events and trends affecting the PBM industry.
Congress Intensifies Tampon Safety Efforts and FDA Takes Steps to Respond
September 25, 2024|
In its August 2024 issue, the journal Environmental International published an article called Tampons as a Source of Exposure to Metal(loid)s. The article reports on the results of a recent study by researchers from Columbia, UC Berkeley, and Michigan State that evaluated the presence of metals in different tampons. The research team evaluated 60 samples of tampons, representing 30 unique products from 24 different brands, for the presence of 16 different metals. The researchers found that all the tampons evaluated contained measurable concentrations of each of the 16 metals, including toxic metals such as lead, arsenic, and zinc.
2024 Pre-Election Analysis: Health Care Issues
August 26, 2024|
Read about different health care priorities that may be pursued by the presidential candidates Donald Trump and Kamala Harris in the latest edition of our 2024 Pre-Election Analysis series on how the November 2024 election will impact the legislative and regulatory landscape.
CMS Issues Final Notice on Program for Breakthrough Device Reimbursement but Industry Looks to Congress for More Inclusive Solution
August 19, 2024|
CMS’s failure to address stakeholder proposals to modify the TCET program has increased interest and advocacy around Congress’s consideration of the Ensuring Patient Access to Critical Breakthrough Products Act. We explore both the shortcomings of the TCET pathway and the possible legislative solutions to its perceived gaps below.
Washington Shake-Up: Vice President Harris to Lead Democratic Nomination for 2024 Presidency
July 25, 2024|
Read about President Biden’s recent withdrawal from the 2024 presidential election and his endorsement of Vice President Kamala Harris as the Democratic nominee, including her stance on technology, climate change, health care, and tax policy.
New Biden Executive Order Emphasizes Women’s Health
March 27, 2024|
On March 18, President Biden signed an executive order (EO) that contributes to the administration’s objective to create solutions to long-lasting women’s health issues that have been historically understudied and under-evaluated.
FTC Hosts Panel and Launches Public Inquiry with DOJ and HHS on Private Equity and Health Care
March 6, 2024|
Read about the FTC’s March 5, 2024 workshop on private equity (PE) investments in the health care industry and a joint request for information on the effects of PE transactions in the health care industry issued by the FTC, DOJ, and HHS.
ARPA-H Commits $100 Million to Accelerate Women’s Health Research through Sprint for Women’s Health
February 28, 2024|
Read about Sprint for Women’s Health, a first-of-its-kind initiative to commit $100 million for research and development in women’s health, announced by the Advanced Research Projects Agency for Health.
ML Strategies Outlook: Federal Action Post-Dobbs Decision
July 25, 2022|
Look Ahead: Upcoming Congressional Work Period – July 2022
July 11, 2022|
The next three weeks will be full of activity in Washington D.C., as the House of Representatives and Senate are working to push their legislative agendas to garner support from their constituents ahead of an August recess and before political “silly season” officially kicks in ahead of the upcoming mid-term elections in November. Here’s our latest update on what you can expect in Congress during the July work period.
Webinar Recording: COVID-19: An Update for Families and Children as Restrictions Are Eased
July 28, 2021|
Throughout the COVID-19 pandemic, information has continuously evolved surrounding the virus and its effects on nearly every aspect of family and public life, particularly on families trying to balance work with remote or in-person learning for their children. In this webinar, two experts from MassGeneral Hospital for Children (MGHfC) discussed current updates surrounding the effectiveness and safety of COVID-19 vaccines for children.
Looking Ahead: FDA in 2021
January 8, 2021|
The U.S. Food and Drug Administration had a busy 2020, as detailed in earlier blog posts. This blog post explores politics and a few policy activities we’ll be keeping an eye on in 2021 and how they might impact medical product manufacturers, particularly now that we know the U.S. Senate will be controlled, like the U.S. House of Representatives and the White House, by Democrats.
Post-Election 2020 - Health Care Preview
November 23, 2020|
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.
Next Steps for 21st Century Cures 2.0
May 7, 2020|
Collaborative Communities
February 27, 2020|
Aaron Josephson explains why FDA is looking to Collaborative Communities to help solve challenges in 2020 and the potential benefit to companies who participate in the development of public policy.
FDA User Fees: Highlights from FDARA & Our Forecast for the Next Round
February 3, 2020|
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