Back to Results
First PageMeta Content
Coagulation system / Medicine / Quality / Clinical research / Factor VIII / Verification and validation / Validation / Von Willebrand disease / Coagulation / Pharmaceutical industry / Blood / Validity


Summary Basis for Regulatory Action Orphan Designation 22 October 2014 Natalya Ananyeva, PhD, Committee Chairperson
Add to Reading List

Open Document

File Size: 279,94 KB

Share Result on Facebook

Company

Introduction Baxter Healthcare Corporation / Inspiration Biopharmaceuticals Inc. / Control Cell Bank System / Baxter Healthcare Corporation / /

Country

France / United States / /

Event

FDA Phase / Product Issues / /

Facility

Baxter’s facility / Facility Bioresearch Monitoring Labeling Epidemiology Lot Release Testing Plan / /

IndustryTerm

cell bank / manufacturing step / prospective process validation protocol / rubber closures / mm butyl rubber stopper / manufacturing process steps / manufacturing processes / manufacturing process / intended commercial site / rpFVIII product / manufacturing / historical manufacturing data / manufacturing capability / cell bank system / /

MedicalCondition

rare bleeding disorder / Sterility / hypersensitivity / MS / serious disease / FVIII deficiency / von Willebrand disease / /

Organization

World Health Organization / WCB / Baxter BLA / MCB / Mary Malarkey____________________________ Office Signatory Authority / FDA / Advisory Committee / DP PV / End-of-Production / /

Person

Igor Bacik / Lokesh Bhattacharyya / Hyesuk Kong / Loan Nguyen / Dennis Cato / Lisa Faulcon / Jeremy Wally / Jie He / Ze Peng / Carl-Michael Staschen / Thomas Maruna / Jay S. Epstein / Nissa Brown-Baker / Grainne Tobin / Wambui Chege / Qiao Bobo / Mary Malarkey / Alexey Khrenov / Karen Campbell / Catherine Poole / Natalya Ananyeva / Boris Zaslavsky / Alfred Del Grosso / Nannette Cagungun / /

Position

Regulatory Project Manager / Chairperson / representative / /

Product

sodium chloride / Sterile Water For Injection / calcium chloride / plasma / for / OBIZUR Page / /

ProvinceOrState

Indiana / /

PublishedMedium

the Priority Review / /

Technology

antibodies / Biotechnology / process control / prospective process validation protocol / simulation / /

SocialTag