Anyone who has spent any time around health care policymaking circles in Washington, D.C. has heard about the intense five-year cycle Congress goes through in order to reauthorize the biggest user fee programs at the Food and...more
On May 4, 2022, House Energy and Commerce (“E&C”) Committee leaders unveiled the legislative package to reauthorize the U.S. Food and Drug Administration (“FDA” or the “Agency”) user fee agreements (the “House Draft”)...more
Congress recently returned from its two-week recess with an extensive to-do list. Between now and the August recess, the House will be in session for a total of 32 legislative days, and the Senate will be in for 54...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
As the 117th Congress moves into its second legislative session, there is no shortage of health care policy issues dotting the landscape. The COVID-19 pandemic, legislative gridlock and a 2021 that was largely locked down by...more
Arnall Golden Gregory LLP's Food & Drug Newsletter is a monthly update of legal and regulatory issues that affect the FDA-regulated community and highlights articles from members of our Food & Drug practice, as well as from...more
Following months of anticipation by stakeholders including patient organizations, research institutions and medical product developers, Representatives Fred Upton (R-MI) and Diana DeGette (D-DO) released a 21st Century Cures...more
Although the Biden-Harris Administration that assumed control of the Executive Branch on January 20, 2021 immediately ordered a regulatory freeze of new or pending rules while the new administration gets its bearings, several...more
This week in Washington: COVID-19 bill negotiations continue. Congress - Hearings/Markups - Senate Committee on Finance: Part 1: Protecting the Reliability of the U.S. Medical Supply Chain During the COVID-19...more