FDA Urges Development Of Generic Alternatives To Bring Down Prices Of Complex Drugs
Given the pressing need for more affordable versions of complex drug products like peptides, liposomes, transdermals and metered dose inhalers, FDA is encouraging generic drug companies to submit more applications for generic alternatives. FDA encourages industry to leverage agency-sponsored research for more advice on how to submit applications that will get approved.
You may also be interested in...
AbbVie is buying Allergan for its product sales, both to increase its own revenues and to fund future R&D and business development, so Allergan's Q2 gains are good news.
Approval rates for complex-drug pre-ANDA meeting requests are climbing. FDA’s hope is that the meetings will hasten approvals of these hard-to-manufacture generics, which could put a dent in US healthcare costs.
FDA will be able to give scientific advice and sponsors can familiarize reviewers with upcoming generic applications for complex products under new provision in GDUFA II.