RT Journal Article SR Electronic T1 Application of Good Manufacturing Practice Regulations To Investigational Biologic Products JF PDA Journal of Pharmaceutical Science and Technology JO PDA J Pharm Sci Technol FD Parenteral Drug Association (PDA) SP 348 OP 351 VO 34 IS 5 A1 Paul W. Goebel YR 1980 UL http://journal.pda.org/content/34/5/348.abstract AB A discussion of the Food and Drug Administration’s authority to regulate investigational biologic products; the changes that were necessary with the inclusion of biologies under Part 211, Good Manufacturing Practice regulations, and procedures currently in effect to assure integrity of the test article and compliance with Good Manufacturing Practices.