FDA guidance may ease path to biosimilar interchangeability
FDA publishes final guidance on ANDA/505(b)(2) NDA pathways
FDA’s Bendeka decision reverses approvals of Treanda generics
Would you like an extra application with that? FDA mulls requiring dual applications for combination products
Pharma Companies May Benefit from Proposed Patent Law Changes in China; Public Comment Invited
Likely FDA Impact of the Government Shutdown: Regulatory Submission Reviews, Inspections, and Research Projects
Four new FDA guidances and proposed rule advance biosimilars policy framework
Supreme Court Issues Landmark Biosimilar Ruling
FDA Announces Policy for Unique Nonproprietary Names for Biologics and Biosimilars
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