The U.S. House Energy and Commerce Committee needed two days of hearings to get through a spending measure that provided the FDA with $500 million for its part in the government response. The CDC would receive $7.5 billion for vaccine distribution and tracking, all developments that ran parallel to an announcement that another 200 million doses of vaccine will be delivered by the end of July at a cost of $3.7 billion.

PERTH, Australia – Australia’s Therapeutic Goods Administration is proposing changes to its fees and charges and is asking stakeholders for feedback on three different proposed fee structures for the 2021-2022 financial year.

Among the low-hanging fruit for pruning back U.S. drug prices is the development of generics referencing complex drugs, a category that includes drug-device combination products and nonbiologic drugs with a complex molecular base, route of administration or formulation, such as abuse-deterrent opioids.

LONDON – The World Health Organization’s (WHO) mission to Wuhan has rejected accidental laboratory escape as the source of the SARS-CoV-2 pandemic, but failed to uncover satisfactory evidence of its exact origin.

U.S. FDA warning letters have been a staple of regulatory life since the late 1990s, but James Boiani, a regulatory attorney with Epstein, Becker & Green P.C., said it’s no stretch of the imagination that warning letter volumes will jump in 2021. This is to some extent because the volume of warning letters dropped significantly over the past four years, and Boiani advised that all FDA-regulated industries will see more warning letters unless they are communicative with the agency about inspectional findings.

In a task made more challenging by COVID-19, the EU and the World Health Organization are rolling out separate plans to take down cancer in Europe. The European Commission Feb. 3 announced its Europe’s Beating Cancer Plan, the first comprehensive European cancer initiative in nearly 30 years. A day later, WHO/Europe launched its United Action Against Cancer, billing it as a “pan-European cancer movement” to galvanize support and cooperation from grassroots to governments with the long-term goal of eliminating cancer as a life-threatening disease in the region.

While the Biden administration’s America Rescue Plan began its journey through Congress Feb. 3 as the next U.S. effort to address the COVID-19 pandemic, lawmakers came together to identify steps to improve vaccine distribution and curb ongoing supply shortages.