FDA gives another year for biologics CMC pilot applications
This article was originally published in The Gold Sheet
FDA Sept. 17 pushed back the Sept. 30 deadline by a year for requests to participate in its chemistry, manufacturing and controls submission pilot for large-molecule products. FDA also expanded the slots for original applications to eight from five for the expanded change protocol pilot, patterned after a 2005 CMC pilot for applying new design space and risk-based concepts to small-molecule drugs
You may also be interested in...
Investors in surgical robotics company Auris say Johnson & Johnson failed to support the company per their merger agreement.
based firm, which markets Activa hand sanitizers, is offering Self+ immunity supplements in Brain, Energy and Unwind formulations in powder format for mixing with water.
Pink Sheet reporters and editors discuss their take-aways from the recent advisory committee meeting on coronavirus vaccine development and approval, as well as the upcoming FDA hearing on Makena’s withdrawal.