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PubMed

Communicating Healthcare Economic and Pre-approval Information With Healthcare Decision-Makers: Opportunities Following the 21st Century Cures Act and FDA Guidance.

PMID: 30488029 ·

A, l, e, x, a, n, d, e, r, , N, i, y, a, z, o, v, ;, , D, e, n, i, s, e, , L, e, n, c, i

RevistaFrontiers in public health
Año
PMID30488029

Resumen

With rising US healthcare costs, population health decision-makers have expressed interest in receiving pre-approval information to help with the budgeting and forecasting needed to accommodate pharmaceutical and medical device launches. Additionally, there has been a strong emphasis placed on the economics and quality of new products. Manufacturers have historically been reluctant to share pre-approval or healthcare economic information (HCEI) due to unclear regulatory guidance for these types

Fuente oficial

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