Exclusive Drug Development Science Office Created By FDA
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Exclusive Drug Development Science Office Created By FDA

An exclusive office of drug development science is being created by FDA as stated by BioCentury reports, to reduce the cost of bringing new medicines to the patients. FDA Commissioner Scott Gottlieb, M.D., is expected to reveal the new office after Tuesday through a video link in the J.P. Morgan Healthcare Conference.

“We believe the time has come to create the science of drug development a more formal scientific discipline within the new drug approval process, in addition to the elements that it contains,” said Gottlieb to BioCentury.

Groups were made out of the 51 people in the Office of Drug Evaluation Science who would be focusing on clinical outcome assessments, safety analytics, and biomarker development. Around one-fifth of their office’s workforce will concentrate on producing more structured approaches towards the evaluation of biomarkers, which Gottlieb believes are prepared to play a”more formal” function in drug development and review. One strand of the biomarker unit’s actions will attempt to develop standards in cooperation with drug developers, academics and other stakeholders.

Gottlieb said another set of office’s 51 employees will work on biomedical informatics and safety analytics and would build a standardized tool

for capturing and formatting data safety in order to make the agency’s reviews for safety data more structured and consistent. If the initiative progresses as expected, it is going to serve as a stepping stone to a different method of managing drug application reviews. A new approach builds on advances in cloud computing and data handling which would give the FDA a more active role in how the information underpinning filings are presented and evaluated has been foreseen by Gottlieb.

Gottlieb stated Cloud-based applications would be there and instead of evaluating the sponsor’s tables and charts, the bottom line data will be pulled formatting it through own assessment tools creating our own charts and tables for the evaluation.