PLAIR - New FDA Guideline Regulates Import of Non-Approved Drugs in the Run-Up to the Launch in US

Applicants expecting an approval for their product for the American market are usually striving to receive an import permit for the still-unapproved drug from FDA. By doing so, applcants will be prepared for the day when the approval letter arrives to be able to serve the American market without delay. This "pre-launch activities importation request" (PLAIR) is currently still regulated on a case-by-case basis. However, according to FDA, these regulatory practices are supposed to be replaced by a standardised approach. FDA has, therefore, developed a guideline draft entitled "Guidance for Industry — Pre-Launch Activities Importation Request (PLAIR)".

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