Digital Innovation in Medicinal Product Regulatory Submission, Review, and Approvals to Create a Dynamic Regulatory Ecosystem-Are We Ready for a Revolution?

Frontiers in Medicine
Judith Catherine MacdonaldKaty J Page

Abstract

The pace of scientific progress over the past several decades within the biological, drug development, and the digital realm has been remarkable. The'omics revolution has enabled a better understanding of the biological basis of disease, unlocking the possibility of new products such as gene and cell therapies which offer novel patient centric solutions. Innovative approaches to clinical trial designs promise greater efficiency, and in recent years, scientific collaborations, and consortia have been developing novel approaches to leverage new sources of evidence such as real-world data, patient experience data, and biomarker data. Alongside this there have been great strides in digital innovation. Cloud computing has become mainstream and the internet of things and blockchain technology have become a reality. These examples of transformation stand in sharp contrast to the current inefficient approach for regulatory submission, review, and approval of medicinal products. This process has not fundamentally changed since the beginning of medicine regulation in the late 1960s. Fortunately, progressive initiatives are emerging that will enrich and streamline regulatory decision making and deliver patient centric therapies, if they a...Continue Reading

References

Dec 16, 2010·Pharmacoepidemiology and Drug Safety·Jeffrey A LinderDavid W Bates
Aug 9, 2017·Frontiers in Medicine·Niels Grønning
Sep 14, 2019·International Journal of Pharmaceutics: X·Lawrence X YuSusan Rosencrance
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Oct 11, 2020·Clinical Cancer Research : an Official Journal of the American Association for Cancer Research·R Angelo de ClaroRichard Pazdur

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Adobe acrobat
ACCESS
Knowledge Aided Assessment and Structured Application ( KASA )
Accumulus Synergy
Transcelerate
acrobat
ASTER ADE
Synergy
eCTD
Adobe

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