Latest From Brenda Sandburg
‘Everything is on the table,’ including invoking the Defense Production Act, White House COVID Coordinator Zients notes. Results of J&J’s Phase III vaccine trial expected ‘within next few days to a week.’
New round of orders would give the US all the vaccine it needs from the existing mRNA products, taking pressure off AstraZeneca as it experiences manufacturing challenges and the EU considers export restrictions to ensure it gets enough vaccine.
US FDA final guidance describes possible study design to test whether selected names may misbrand a drug. Agency also okays use of two-letter USAN stems in product names and clarifies use of modifiers.
FDA’s Amy Abernethy describes how agency’s use of real-world data has evolved in response to COVID-19 and the ‘a-ha’ moment of leveraging different data sources to understand the coronavirus. Takeda R&D President Andrew Plump notes difficulties with platform trials and limitations on data sharing.
If Biden administration wants to nominate the acting commissioner, Vacancies Reform Act would dictate the timing. Woodcock can still get the nod and remain head of the agency during the confirmation process, just as Andrew von Eschenbach retained his acting title following his nomination in 2006.
President Biden’s picks to fill two commissioner posts may shift dynamics on pharmaceutical industry enforcement. Rohit Chopra’s nomination to Consumer Financial Protection Bureau removes strong critic of pharma mergers.