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Tag Archives: FDA
A Blueprint for FDA Reform
The FDA five-year strategy emphasizes a more coordinated—and skeptical—response to globalization of the drug supply chain. On balance, the strategy continues to focus more on managing risk than assessing benefit—industry take heed.
Earlier this month, FDA released a five-year, forward-looking strategic priorities report—“Responding to the Public Health Challenges of the 21st Century”—that outlines what the industry [...]
Governor Howard Dean: Financing the Future of US Drug Innovation
Will it be More Good Pills — Or that Porsche?
The Obama Administration’s signal achievement to date — passage of comprehensive health reform legislation — continues to inspire confusion and contradictions across the political spectrum. Despite its scope, the bill is dismissed by many Democrats for what it does not do, while the GOP [...]
Posted in FDA, R&D, Regulatory, healthcare Also tagged Health Reform, healthcare, Howard Dean, Obama, Obamacare 1 Comment
Two 'Most Promising' New Drugs Face Setbacks in US
Two of the drugs named “most promising” in Thomson Reuters’ recent quarterly report hit snags in the US, despite European approval.
Those two products – AstraZeneca’s Brilique (Brilinta in the US), a blood thinner, and Pharming’s Ruconest (Rhucin in the US) – were held up during FDA’s review process. Brilique (ticagrelor), AstraZeneca’s leading pipeline drug, was [...]
Posted in FDA, Global, R&D, Regulatory, Sales Also tagged AstraZeneca, Brilique, Pharming, Ruconest, Thomson Reuters Leave a comment
FDA Approvals Down on Last Two Years
A new FDA report summarizes the new drug approvals for 2010, and highlights some surprising numbers compared to years past.
According to a recent FDA report, FDA’s Center for Drug Evaluation and Research (CDER) approved 21 New Molecular Entities (NMEs) in 2010, which is less than in 2009 (26) and 2008 (24), but greater than the [...]
CDER Addresses 'Challenges of Globalization' With a New Office