Division of Apotex Inc.
Latest From ApoPharma Inc.
The Center for Drug Evaluation and Research is becoming more comfortable approving new molecular entities and novel biologics without first seeking the views of its outside experts. In 2011, 13 of the 30 novel therapeutics cleared did not undergo advisory committee scrutiny beforehand.
The Oncologic Drugs Advisory Committee review of ApoPharma’s Ferriprox was not one of the highest profile meetings of the past year. But for sponsors concerned about the availability of the accelerated approval pathway, it was a very important event.
FDA is entering a big legislative year with a good story to tell based on 30 new molecular entity approvals. But the level of submissions remains constant—suggesting it may be time to shift the focus from what comes out of FDA to what makes it in.
- Therapeutic Areas
- Blood & Coagulation Disorders & Products
- North America
- Parent & Subsidiaries
- Apotex Inc.
- Senior Management
- Michael Spino, Pres.
- Contact Info
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