{"title":"Guess Who’s Coming to Inspect R&D?","authors":"R.D. McDowall","doi":"10.56530/spectroscopy.cv2490n6","DOIUrl":null,"url":null,"abstract":"A new revision to the U.S. Food and Drug Administration (FDA)’s Compliance Program Guide for Pre-Approval Inspections (PAIs) has added a fourth objective: Commitment to Quality in Pharmaceutical Development. PAIs are going to be very interesting now.....","PeriodicalId":21957,"journal":{"name":"Spectroscopy","volume":"13 1","pages":"0"},"PeriodicalIF":0.8000,"publicationDate":"2023-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Spectroscopy","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.56530/spectroscopy.cv2490n6","RegionNum":4,"RegionCategory":"化学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q4","JCRName":"SPECTROSCOPY","Score":null,"Total":0}
引用次数: 0
Abstract
A new revision to the U.S. Food and Drug Administration (FDA)’s Compliance Program Guide for Pre-Approval Inspections (PAIs) has added a fourth objective: Commitment to Quality in Pharmaceutical Development. PAIs are going to be very interesting now.....
期刊介绍:
Spectroscopy welcomes manuscripts that describe techniques and applications of all forms of spectroscopy and that are of immediate interest to users in industry, academia, and government.