Biologics Safety: Stronger Pharmacovigilance For First-In-Class BLAs Urged In JAMA Report
This article was originally published in The Pink Sheet Daily
Executive Summary
Over 23 percent of biologics were subject to post-approval “Dear Doctor” communications or black box warnings during a 12-year period, study finds.
You may also be interested in...
Most Biosimilars Would Need Clinical Trials, ASCO Tells House Panel
While urging Congress to write legislation that allows FDA to decide which scientific data are needed to approve follow-on biologics, comments from the American Society of Clinical Oncology to a House subcommittee note that clinical trials will be necessary for most FOBs
Rx Misbranding Penalties Should Be Stronger To Stop Counterfeiting, FDA Says
Industry also seems supportive of the idea, while Pew touts the power of the power of track-and-trace as a deterrent.
Track-And-Trace: With Deadline a Year Away, Some Lessons from Early Adopters
EMD Serono has been tracking Serostim packages since 2002; J&J is using Prezista 600 mg as a trial run for serialization.