More e-cigarettes, nicotine pouches allowed in US, to FDA staffers’ surprise

The new policy will allow companies to launch certain nicotine-based products before they’ve been fully vetted by regulators.

FDA staff blindsided by move allowing more e-cigarettes and nicotine pouches onto US market

Senior officials in the Food and Drug Administration’s tobacco center were blindsided by a recent decision that opens the ...

Gilead's drug wins first-ever US approval for deadly liver infection

May 22 (Reuters) - Gilead Sciences said on Friday that its experimental drug for a rare and deadly liver infection that had ...
Regulatory Affairs Professionals Society

FDA official: 17 drugs approved using continuous manufacturing, growth seen in emerging tech program

Adam Fisher, the staff director of the Office of Pharmaceutical Quality in the Center for Drug Evaluation and Research (CDER) ...

US FDA approves Gilead's drug for deadly liver infection

Food and Drug Administration ‌said on Friday it ‌approved Gilead Sciences' drug for a ​rare and deadly liver infection that ...

US FDA mulls repurposing approved drugs to expand access

Food and Drug Administration said on Monday it is seeking input on repurposing ‌approved drugs for potential new uses across ...

US FDA to hold expert committee meeting to review Moderna's flu vaccine

May 21 (Reuters) - The U.S. FDA said on Thursday it would hold a meeting of outside experts next month to review Moderna's experimental flu shot. Moderna's mRNA-based seasonal flu vaccine is currently ...
C&EN

FDA launches multipronged attack on flu vaccines

The US Food & Drug Administration refused to review Moderna’s mRNA flu vaccine this week. Regulators had already shaken up the industry by requiring new safety warnings and don’t appear to be on track ...