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Medicare Price Negotiation: Sponsors Will Have A Say, But Likely Not Sway As Timetable Comes Into Focus

 
• By Cathy Kelly

CMS details when it will release information and receive public comments in the lead-up to publishing the initial list of drugs to be negotiated this fall.

Opportunities For Manufacturers To Shape Program? • Source: Shutterstock

Although not required to by the Inflation Reduction Act, the Centers for Medicare and Medicaid Services will seek public comment on guidance and a handful of information collection requests covering the initial implementation of the Medicare price negotiation process over the next several months in an effort to leverage stakeholder expertise as it “thoughtfully” designs the program.

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Brazil’s ANVISA Clarifies Registration Procedures For Biologicals

 
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Brazil’s drug regulator has published a new technical note updating guidelines on registration and post-registration procedures for biological products.

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