ICD Code Breaking: Rare Disease Advocates Want Simpler, Shorter Nomination Process
A group would look at the diseases that need codes and which to add initially, then consider updates to the code nomination process, in an effort to lower costs for rare disease patients.
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Complete Response Letters: US FDA Tells Congress Broader Disclosures To Sponsors Could Be ‘Chilling’
A lengthy hearing that addressed everything from Aduhelm to advanced manufacturing serves as the formal kick off of the user fee reauthorization season and offers a preview of many possible FDA reforms that House members could seek to include in the legislation.
PDUFA VII Will Fund Pregnancy Postmarket Safety Update, Sentinel Upgrades, REMS Standardization
US FDA will incorporate performance goals for reviewing REMS methodological approaches and study protocols as part of PDUFA reauthorization.
Drug Costs Not A Primary Driver Of Rare Disease Economic Burden
EveryLife Foundation study finds inpatient and outpatient care, not prescription drugs, are the primary excess medical costs associated with rare diseases.