TY - BOOK ID - 134659922 TI - Guidance for FDA reviews and sponsors : content and review of chemistry, manufacturing, and control (CMC) information for human gene therapy investigational new drug applications (INDs). PY - 2008 PB - Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research, DB - UniCat KW - Gene therapy. KW - Drug approval UR - https://www.unicat.be/uniCat?func=search&query=sysid:134659922 AB - ER -