FDA expedites drug/biologic development and approval

Thursday, October 15, 2015

The FDA has created four mecha­nisms to expedite development and approval of drugs and biologics that effectively treat serious diseases: Accelerated Approval, Breakthrough Therapy Designation, Priority Review and Fast Track Designation. Under­standing the requirements and ben­efits of each can inform decisions for your development program.

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FDA voices concerns about its expanding mission

Monday, October 5, 2015

Citing how its mission continues to be “at risk,” the FDA—in a new report from its Science Board—said the agency’s expansion and extraordinary range of increasingly complex responsibilities and insufficient resources needs to be addressed soon.

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FDA warns Sironis for unapproved trial

Monday, September 28, 2015

The FDA has sent a warning letter to Sironis, a medical devices and software developer, for running an unapproved clinical trial of its LIR closed-loop fluid administration system. The FDA said the Newport Beach, Calif.-based company never sought the proper approvals.

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NIH seeks ways to combine genomic information and EHRs

Wednesday, September 9, 2015

A dozen awards from the NIH will support research that incorporates DNA sequence information into electronic medical records. The goal of research conducted by the Electronic Medical Records and Genomics (eMERGE) network is to better understand the genomic basis of disease and to tailor medical care to individual patients based on their genomic differences.

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