Have you submitted a variation to the authority of reformulated prodcut to reduce the nitrosmaine formation?
If yes, what type of bridgin studies have you provided? Which studies the authority asked you to provide?
Accdorgint to FDA: * For approved NDAs and ANDAs that require reformulation as part of a mitigation strategy, in vitro or in vivo bioequivalence bridging studies.
But it’s not clear what sort of studies (other than BE study).
Updates on possible mitigation strategies to reduce the risk of nitrosamine drug substance-related impurities in drug products | FDA.
Looking forward to knowing your experince.