PDUFA And Gene Therapy: Bring ‘Fully Baked’ Ideas And ‘Don’t Be Stingy,’ Grogan Tells Developers
Former chief of White House Domestic Policy Council advises cell and gene therapy companies on strategies for promoting enhanced FDA review capabilities as part of Prescription Drug User Fee Act reauthorization negotiations.
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Multiple stakeholders call for CBER to receive more prescription drug user fee funds amid growing cell and gene therapy popularity.
Germany uses government facilitated price negotiations between publicly funded insurers and manufacturers that are based on an independent assessment of how much added value a drug provides.
Teva, Sun and the AAM are among those urging the CMS to rescind its proposal to reimburse Part B drugs approved under section 505(b)(2) as multiple source products. The proposal would target one relatively small but growing part of Medicare Rx spending and reflects CMS’ ongoing concern with fast rising costs in the program.