The incoming Trump administration has sent many signals that it intends to ramp up the Department of Defense’s use of nontraditional acquisition pathways to bridge the “Valley of Death” and bring innovative technologies to...more
Last week, Acting Secretary of the US Department of Health and Human Services (HHS) Dorothy Fink instructed federal health agencies within the HHS to freeze all external communications, including health advisories, weekly...more
In previous Updates, we discussed the formation and growth of the Biopharmaceutical Manufacturing Preparedness Consortium (BioMaP-Consortium), which was started by the Biomedical Advanced Research and Development Authority...more
In a previous Update, we reported on the Biomedical Advanced Research and Development Authority’s (BARDA) plans to implement the new Biopharmaceutical Manufacturing Preparedness-Consortium (BioMaP-Consortium or Consortium),...more
The Biomedical Advanced Research and Development Authority (BARDA) held its first in-person BARDA Industry Day (BID) since the beginning of the COVID-19 pandemic in Washington, D.C., on November 13-14, 2023. BID is an annual...more
As part of the Biden Administration’s ongoing efforts to spur innovation and research, it has championed the creation of a new sub-agency within the Department of Health and Human Services, the Advanced Research Projects...more
There were so many interesting and significant developments related to the various missions of the U.S. Food and Drug Administration (FDA) during the last week or so of September 2022 that we decided to create a summary...more
On September 27, 2022, the U.S. Food and Drug Administration (FDA) updated its COVID-19 Test Policy Guidance to encourage test developers to pursue full marketing authorization as opposed to Emergency Use Authorizations...more
On March 15, 2022, the Senate Health, Education, Labor and Pensions Committee (HELP) held a full committee markup to offer several amendments and vote on S. 3799, the Prepare for and Respond to Existing Viruses, Emerging New...more
Following nearly a year of committee hearings, research, policy briefs, and discussion with agency experts, the Senate Health, Education, Labor, and Pensions (HELP) Committee Chairwoman Patty Murray (D-WA) and Ranking Member...more
For several years, policy-makers and commentators have expressed concern about the resilience of the United States’ pharmaceutical supply chain. Current U.S.-based manufacturing capabilities have been at the forefront of...more
We have seen biopharmaceutical companies around the world partnering to tackle COVID-19 in diagnostics, treatment development, vaccine development, and other relief efforts, including monetary and in-kind donations of lab...more
When the Biden Administration begins, the government contracting community may be wondering whether the change in administration and party in the White House will lead to significant changes to federal procurement. Although...more
The incoming Biden Administration promises a more nationalized approach to combatting the COVID-19 public health crisis, plus a large economic stimulus response focused on unemployment, paid leave, state and local government...more
On August 4, 2020, a bipartisan coalition of over 30 attorneys general led by California Attorney General Xavier Becerra and Louisiana Attorney General Jeff Landry sent a letter request to United States Health and Human...more
As the COVID-19 pandemic spreads throughout the United States and Americans anxiously await the arrival of a vaccine, biotech companies are grappling with the uncertainty of patent protection for COVID related biomedical...more
On July 6, 2020, the House of Representatives Committee on Appropriations released its draft Fiscal Year (FY) 2021 funding bill for the Departments of Labor, Education, and HHS (the Bill), which includes several interesting...more
While many of us are justifiably focused on the negative aspects of the COVID-19 pandemic, one positive result has been the way in which the life sciences community has answered the call to develop lifesaving medical...more
In Washington: Just as some federal agencies are calling for federal employees who are teleworking to return, several Virginia and Maryland lawmakers are warning that it might be too early. ...more
In Washington: On Saturday, White House trade adviser Peter Navarro said that the White House is targeting a phase four stimulus package focusing on American manufacturing that will be “at least $2 trillion dollars.” ...more
On April 23, 2020, the House of Representatives passed the Paycheck Protection Program and Health Care Enhancement Act, which previously passed the Senate on April 21, 2020, and is expected to be signed into law by the...more