Antibiotics Top List Of New Exclusivity Benefits In Draft Cures Legislation
This article was originally published in The Pink Sheet Daily
Sponsors could transfer or sell some QIDP exclusivity to other products under draft bill, which also offers new exclusivity perks for orphan drugs, 505(b)(2) applications, ANDAs and biosimilars – but GPhA isn’t happy.
You may also be interested in...
Providing a transferable period of patent-life extension in exchange for US FDA approval of a new antibiotic would incentivize ‘the whole ecosystem’ to find new treatments for emerging diseases, CEO Ian Read says.
House 21st Century Cures discussion draft would adjust FDA promotion regulations for Twitter, requiring that information communicated through hyperlink be considered part of the original post.
House Energy and Commerce committee says it’s committed to a bill to accelerate U.S. biomedical innovation before the next FDA user fee cycle, but the wide scope of needs and stakeholders may make crafting legislation challenging – never mind getting it passed.