FDA updates guidance on interchangeability

[6/20/2024] Today, FDA issued a draft guidance for industry “Considerations for Demonstrating Interchangeability with a Reference Product: Update.”This draft guidance describes considerations regarding a switching study or studies intended to support a demonstration...

Malassezia [mal″ə-sē′zhə]

Disclaimer: Early release articles are not considered as final versions. Any changes will be reflected in the online version in the month the article is officially released. Author affiliation: Universidade Metropolitana de Santos, Santos, Brazil (F.P. Sellera);...