Seroquel Generics Suit Is AstraZeneca’s Bid To Control Diabetes Safety Data
Executive Summary
FDA nearly always prevails in lawsuits that challenge generic approvals, but AstraZeneca’s argument is relatively fresh and could be bolstered by the agency’s decision to deny the firm’s citizen petition without comment.
You may also be interested in...
Senate Bill Would Prevent Safety Label Carve-Outs From Delaying Approvals
Updated drug pricing bill would allow US FDA to approve generics even if innovator safety information is protected by exclusivity.
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.
Current Pathways For Rare Disease Drugs Are Not Optimal, US FDA’s Califf Says
Anticipating a ‘tsunami of therapies’ for rare diseases, commissioner says the agency will have to think of creative approaches and employ regulatory flexibility for them. FDA considers copying the oncology center’s Project Facilitate for expanded access to other diseases.