Biosimilar Analytics Draw More FDA Focus At Celltrion Inflectra Committee, But…
Executive Summary
Agency also spent lot of time assuring advisory committee members that some product differences are not as important as others.
You may also be interested in...
Biosimilar Advisory Committees Getting Smoother, Even As Worries Stay The Same
US FDA advisors overwhelming endorse Hospira's biosimilar referencing Amgen's Epogen, but still wanted broader immunogenicity data and postmarketing surveillance.
Biosimilar Advisory Committees Getting Smoother, Even As Worries Stay The Same
US FDA advisors overwhelming endorse Hospira's biosimilar referencing Amgen's Epogen, but still wanted broader immunogenicity data and postmarketing surveillance.
US FDA Hopes Food, Inspection Office Reorg Bolsters Innovative Clinical Trial Adoption
Ensuring inspectors understand the innovative trial designs in use before an inspection will be important to increasing industry confidence in their use, CDER Director Patrizia Cavazzoni said.