PDSA Letter Re: DSCSA Q&A
Source: PDSA
Since the enactment of the DSCSA members of PDSA have identified a number of questions that are not clearly answered by the plain language of the DSCSA and create operational issues. Working together, members from all sectors of the supply chain have developed answers to these questions that PDSA believes constitute reasonable and appropriate interpretations of the statutory text and account for the operational realities faced by supply chain participants.
Keywords: grandfathering, contract manufacturer, CMO, NDA, ANDA, BLA, transaction, requests for information, validation, patient assistance, clinical trials, wholesale distributor database, drop shipment