The firm brings unique experience to tracking, assessing and explaining regulatory and reimbursement policy that affect the biopharmaceutical industry. The company’s goal is to advance mutual understanding among policymakers, business executives and the investment community, in the belief that a deeper understanding of policy leads to better business, and a deeper understanding of business leads to better policy.
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- “Expedited” Device/Diagnostics Guidance Uses “Breakthrough Therapy” All-Hands-On-Deck Approach Apr. 23, 2014
- QRx/Actavis’ Moxduo Morphine/Oxycodone Combo Rejected By Advisory Committee; Path Forward Unlikely Apr. 22, 2014
- Orphan Drugs And Biosimilars: MAb Guidance Makes Clear Orphan “Sameness” Standard Is Separate From Biosimilarity Apr. 22, 2014
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