Biosimilars: FDA's Meeting Notice Upgrades Safety To "Paramount"
This article was originally published in The Pink Sheet Daily
Executive Summary
Updated outline of November meeting discussion points includes several tweaks to the pharmacovigilance section.
You may also be interested in...
FDA Signals Interest In Requiring Unique Biosimilar Names
OND Director Jenkins expresses concern at a public hearing that the agency could miss or confuse some spontaneous adverse events if biosimilars are not distinguished from their reference product.
FDA Signals Interest In Requiring Unique Biosimilar Names
OND Director Jenkins expresses concern at a public hearing that the agency could miss or confuse some spontaneous adverse events if biosimilars are not distinguished from their reference product.
ViroPharma Could Manufacture Cinryze "At Risk" Starting Next Year
Delay in application for industrial scale production illustrates the challenges that biosimilar manufacturers will face.