FDA Simplifies Biosimilar Development with New Draft Guidance
The US Food and Drug Administration (FDA) has introduced new draft guidance to streamline and expedite the biosimilar development process.
The regulatory framework aims to reduce the reliance on "unnecessary clinical testing" during the approval process, allowing biosimilar manufacturers to skip comparative efficacy studies on their prospective drugs.
Industry reaction to the draft guidance has been mixed, despite its potential to cut the cost and time-associated burden of biosimilar development.
The gold standard of business intelligence.
By combining business intelligence and editorial excellence, the FDA's guidance can reach engaged professionals across 36 leading media platforms.
Author's summary: FDA simplifies biosimilar development process.
More News
- Sydney Sixers Vs Adelaide Strikers, WBBL 2025: SYS-W Beat AS-W By One Run Thanks To Ellyse Perry Century
- Benin coup attempt foiled by loyalist troops, interior minister says
- Tunbridge Wells gridlocked as residents queue for fresh water after five-day outage
- Tartan Army set for ‘big bash’ in Boston with two games in New England
- Congress gridlocked on key issues as year-end deadline looms
- Canada's Air Transat to suspend flights
- Gridlocked Halloween, 2025, @kaltgatzke flashbang film. I ...
- Another Coup In Africa, Soldiers Appear On State TV To Announce Takeover
- Benin authorities say coup attempt foiled, President Talon safe
- Benin: the government declares coup attempt has been 'foiled'