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Pre-Launch Activities Importation Request (PLAIR) Q&A Document Published by FDA
The Q&A document addresses a number of frequently asked questions about the Pre-Launch Activities Importation Request (PLAIR) process, and when you can or cannot use a PLAIR for importing unapproved drug product into the United States. Quite interestingly, there are quite a few answers of “no” to the FAQs, which likely demonstrates that firms have […]