Preparing for FDA Pre-Approval Inspections (Drugs & the Pharmaceutical Sciences) (Drugs and the Pharmaceutical Sciences)
Edition: 1 edition
Publisher: Informa Healthcare
Published: October 1, 1998
Language: eng
Format: Hardcover
Number of pages: 302
ISBN-13: 9780824702182
Subjects: Pharmaceutical technology; Pharmacology; Pharmacy; Pharmaceutical Research; Medical / Nursing; United States.; Medical; United States; Research; Engineering - Chemical & Biochemical; Medicine; Technology / Engineering / Chemical & Biochemical; Food and Drug Administration; Drugs; Standards
First sentence: A pre-approval inspection is a visit by one or more food and drug investigators to review the adequacy and accuracy of the information provided in a regulatory submission (Compliance Program Guidance Manual, Program 7346.832).