Chemistry, Manufacturing and Controls Changes to an Approved NADA or ANADA
This draft guidance document is being distributed for comment purposes only.
This guidance documen READ MORE http://google.fda.gov/search...
Prepared by: Center for Biologics Evaluation and Research Division of Biochemistry and Biophysics Laboratory of Analytical Chemistry (HFB-740) Food and Drug Administration 8800 Rockvill READ MORE http://google.fda.gov/search...
Compliance Program Guidance Manual - Inspection of Biological Drug Products - 7345.848
CBER-regulated biological drug products include fractionated blood and their recombinant analogues; READ MORE http://www.fda.gov/cber/cpg/7345848.htm
Process Analytical Technology
The goal of PAT is to understand and control the manufacturing process, which is consistent with our current drug quality system: quality cannot be teste READ MORE http://www.fda.gov/Cder/OPS/PAT.htm