TY - BOOK ID - 137753070 TI - Guidance for industry : changes to an approved NDA or ANDA, specifications, use of enforcement discretion for compendial changes. PY - 2004 PB - Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, DB - UniCat KW - Drug approval UR - https://www.unicat.be/uniCat?func=search&query=sysid:137753070 AB - ER -