Latest News & Analysis
Insys' Sublingual Buprenorphine Spray Fails At US FDA Panel, But Some Members See Future In Limited Role
FDA has yet to finalize about one-third of its OTC monographs and several hundred ingredients do not have a final GRASE determination. Sorting will help the agency determine which of the 800 active OTC monograph ingredients are designated as needing more information to establish GRASE under a faster system based on administrative orders.
Despite the benefits in improving product quality and reducing product defects, the pharmaceutical industry is still struggling to incorporate ICH Q9 quality risk management principles into quality operations, and even more dispiriting, there is still lingering uncertainty on what constitutes quality risk management.
African health ministers have agreed on a treaty to set up a new pan-African agency to coordinate regional drug regulatory harmonization initiatives and pool limited regulatory expertise.
Monotherapy patients with tumors that have low PD-L1 expression experienced decrease survival in two confirmatory trials; however, the immune checkpoint inhibitors’ accelerated approvals are unlikely to be affected pending final results comparing use in combination with chemotherapy to chemo alone.
FTC Chief Administrative Law Judge finds procompetitive benefit of Endo-Impax patent settlement agreement outweighs unjustified no-authorized generic provision.
The most surprising proposal coming out the Rose Garden drug pricing event was a call for disclosure of prices in DTC ads. As a policy idea, it may be a dud – but that doesn’t mean it isn’t a critical element of the plan.
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