The draft guidance document discusses the development of labeling for proposed biosimilars and interchangeable biosimilars for submission under section 351(k) of the Public Health Service Act.
Susan Haigney
Advertisement
Articles by Susan Haigney
EMA, the European Commission, and HMAs are phasing out the flexible regulations put into place during the pandemic.
Advertisement
Latest Updated Articles
Advertisement
Advertisement
Trending on Pharmaceutical Commerce
1
BioNTech Launches Public Exchange Offer for CureVac in $1.25B All-Stock Deal
2
Pharma Pulse: Alkermes Acquires Avadel in $2.1B Deal, BioNTech Moves to Buy CureVac, and MedTech Industry Embraces Digital-First Models
3
How Biopharma Companies Can Optimize Field Reimbursement Models
4
Pharma Pulse: MJH Life Sciences Expands into Health Systems, Novo Nordisk Board Shakeup Moves Markets, and Mark Cuban Grows Cost Plus Drugs Network
5
