Generic Sample Access Process For REMS-Protected Brands Now Includes Agency Timeline
US FDA has 120 days to review generic sponsors’ requests for letters to help them obtain product samples, but will not send them to the reference product company.
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Teva dismissed its suit against Amicus Therapeutics after the latter agreed to provide requested quantities of its Fabry disease treatment Galafold. The quick resolution of the complaint illustrates the success of the legislation in halting the drug supply dispute but leaves some unanswered questions.
Amicus should to be forced to sell samples of Galafold (migalastat) for bioequivalence and other testing, Teva argues in what appears to be the initial case brought under the 2019 law intended to smooth the development of ANDAs.
Bill addresses ‘dead zone’ for pending applications for protein products transitioning to biologic status; generic and brand industries each win in different legislative provisions: inclusion of the CREATES Act, and a revised definition for ‘biologics’ that includes chemically synthesized polypeptides.