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On the Fast Track

A US Food and Drug Administration initiative has sped the review and approval process for promising drugs, but researchers from Wake Forest University Medical School note in the Journal of the American Medical Association that some fast-tracked drugs have been associated with safety risks. Thomas Moore and Curt Furberg focus on three drugs — vandetanib, fingolimod, and dabigatran — that have been approved quickly despite some safety concerns and uncertainty regarding dosing. "Although enabling new drugs with a favorable benefit-to-harm balance to become available to patients more rapidly is a laudable goal, the underlying question is what public health risks are taken when drugs are approved for widespread use while important safety questions remain unanswered," Moore and Furberg write.

At Pharmalot, Ed Silver sought comment on the JAMA essay from FDA. A spokesperson told him that the labels for the drugs discussed by Moore and Furberg discuss when it is appropriate for physicians and patients to turn to those drugs. The spokesperson adds that "making regulatory decisions about drugs always involves uncertainty and risk. FDA works directly with the affected patient populations and treating physicians when considering just how much uncertainty and risk are reasonable to accept."

The Scan

Genome Sequences Reveal Range Mutations in Induced Pluripotent Stem Cells

Researchers in Nature Genetics detect somatic mutation variation across iPSCs generated from blood or skin fibroblast cell sources, along with selection for BCOR gene mutations.

Researchers Reprogram Plant Roots With Synthetic Genetic Circuit Strategy

Root gene expression was altered with the help of genetic circuits built around a series of synthetic transcriptional regulators in the Nicotiana benthamiana plant in a Science paper.

Infectious Disease Tracking Study Compares Genome Sequencing Approaches

Researchers in BMC Genomics see advantages for capture-based Illumina sequencing and amplicon-based sequencing on the Nanopore instrument, depending on the situation or samples available.

LINE-1 Linked to Premature Aging Conditions

Researchers report in Science Translational Medicine that the accumulation of LINE-1 RNA contributes to premature aging conditions and that symptoms can be improved by targeting them.