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 been trying to apply the PLAIR process to situations for which it was not intended.
Just look around, watch the television, read the newspaper, and what do you see? Seems like very few reasons to be thankful. School and workplace shootings, the political scene is as nasty as I ever remember in my 70 years on earth. Climate change is threatening the future of our children, and the environmental controls have been set back 50 years as the oceans continue to rise,
I railed about drug importation as a way to lower drug costs in a previous post (here) for numerous reasons. For instance, how can you protect against counterfeit drugs, how do you know how the products are stored and where they have been in the supply chain, and how are you assured of drug product quality?