US FDA Tweaks Guidance On Sameness Of Gene Therapies, But Questions Remain
In response to industry input, the agency made a few changes to its draft guidance but several issues remain uncertain, such as what constitutes ‘minor differences’ between gene therapy products.
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US FDA draft guidance says that ‘minor differences’ in transgenes and/or vectors won’t be enough for orphan exclusivity, but agency will consider ‘additional features of the final product’ in making the determination.
At Solicitor General’s Urging, Supreme Court May Take Up Patent Eligibility Dispute Riling Biopharma
Federal Circuit’s rulings on subject matter patent eligibility have fractured the court, the US government says in advising the high court to review American Axle v. Neapco to provide clarity. BIO, former PTO director Kappos and Sen. Tillis also urge Supreme Court to hear the case.
Decentralized trials are way to help displaced Ukrainians remain in studies and could encourage greater participation from individuals in other countries, those overseeing sites in Ukraine say.