Malcolm Spicer, Managing Editor – US
Latest From Malcolm Spicer
Garbriel Letizia Jr., and employees at AMA Laboratories “at his direction,” defrauded customers of more than $46m by testing products on materially lower numbers of subjects than specified and paid for by the customers.
More time for notifications than current deadline of at least 75 days before NDI-containing product is offered for sale in US doesn’t solve problems with FDA’s management of NDI regulation, say trade groups.
Democrats and Republicans vote to approve $28m emergency finding for FDA formula programs proposed in bill introduced day earlier by Democrat leaders on Appropriations Committee. Biden deems Defense Production Act applicable to manufacturing formula products.
HELP Committee Chairwoman Patty Murray, and ranking member Richard Burr also include supplement registration requirement in discussion draft for reauthorizing FDA’s user fee programs for prescription, generic and biosimilar drugs and medical devices.
Decree imposes steps Abbott must complete before it can begin preparing to restart production, including hiring independent consultant to determine whether facility is compliant with FDA manufacturing and labeling regulations.
Democrats introduce bill two days before Agriculture, Rural Development, FDA and Related Agencies subcommittee will question FDA Commissioner Robert Califf about agency’s oversight of formula industry during a hearing on FY2023 budget.