FDA Pushes Enforcement Discretion Deadline For Infant Formula To Jan. 6

FDA published an immediately-in-effect guidance Friday (Sept. 30) laying out a plan to allow certain infant formula products, including those that have been imported into the United States, to remain on the market under FDA’s current enforcement discretion policy in a bid to sustain and diversify the supply of formula available in the United States. The enforcement discretion policy, announced in May , allows certain infant formulas made overseas and intended for a foreign market, or products manufactured domestically and...
Article Type: 
Site Name: 
InsideHealthPolicy.com
FDA Issue: 
FDA Week - 10/07/2022
FDA Volume: 
Vol. 28, No. 40
Author: 


Senate Cuts Work Session Short; Part D Rebates Kick In; MedPAC To Focus On Implementing Drug Pricing Law

Congress has temporarily funded the government, and the Senate will skip the October work session, returning Nov. 14 with three work weeks to pass omnibus appropriations legislation that is supposed to be the vehicle for FDA policies left out of user fee reauthorization, and Medicare pay policies for doctors and hospitals. Meanwhile, the first measure from the recently passed drug price negotiation law took effect over the weekend, and congressional Medicare advisers are going to focus on the implementation of...
Article Type: 
Site Name: 
InsideHealthPolicy.com
IDP Issue: 
Inside Drug Pricing - 10/03/2022
IDP Volume: 
Vol. 5, No. 40
Author: 














Pages

Log in to access this content.

Not a subscriber? Sign up for 30 days free access to exclusive, detailed reporting on drug pricing reforms, Medicaid policy, FDA news and much more.