ANDA Changes May Require Paragraph IV Recertification, New 30-Month Stay
Executive Summary
Brand litigants are beginning to argue that post-Markman application tweaks are in essence new applications eligible for new 30-month stays.
You may also be interested in...
FDA’s ‘Monster’ Proposed Rule Targets Patent Use Codes, Paragraph IV Certification
Industry has 90 days to comment on FDA’s current handling of generic challenges to brand protections.
Baxter Seeks Unusual Second 30-Month Stay On Generic Version Of Its Anesthetic Suprane
A redesign of the proposed generic and changes to the Paragraph IV certification could give the brand an additional six-month hold on approval of the ANDA.
Companies Reveal Hurdles In Providing Drugs Via Expanded Access Programs
GSK, Stealth BioTherapeutics and Blueprint Medicines discuss the difficulties getting participation of physicians, the excessive cost of expanded access, and whether physicians should report research data.