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PDUFA Negotiations End With Differences To Resolve In Commitment Letter

 
• By Derrick Gingery

The entire PDUFDA VI reauthorization process likely is more than a year from completion, but agreeing on a draft commitment letter is a major milestone for FDA and the pharma industry. It will serve as the foundation of the legislative phase expected to begin in early 2017.

Negotiations on re-authorizing the Prescription Drug User Fee Act are completed, but it appears that industry and likely FDA are continuing to vet the draft commitment letter for final approval.

Both FDA and industry agreed Jan. 29 to take the draft commitment letter and proposed statutory changes to their senior management for ratification, according to

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More from North America

‘Tectonic’ Arkansas PBM Legislation May Upend Industry

 
• By Tim Casey

Industry will fight hard to prevent other states or the federal government from adopting measures similar to Arkansas' law preventing PBMs from owning pharmacies.

Will International Prices Influence Medicare Price Negotiation?

 
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A former CMS official suggested the most likely way it could happen is through a Center for Medicare and Medicaid Innovation demonstration.

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• By Sarah Karlin-Smith

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