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FDA Adds OTC Monograph Staff By Shifting CDER Appropriations

 
• By Malcolm Spicer

CDER will add five staff members to expand to 23 the number committed to working on the monograph program, an unexpected development for the OTC industry especially in light of FDA's proposals for monograph program user fee.

Business time concept as a group of running businessmen and businesswomen using a giant clock to cross over a cliff as a bridge as a metaphor for schedule and appointment speed as a 3D illustration.

FDA is dipping into its direct appropriation for staff, shifting resources to have more staff to work on its OTC monograph program.

The move comes as agency officials and drug industry stakeholders are discussing whether to ask Congress to authorize a user fee

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More from North America

New Guidance Suggests SubQ Keytruda, Opdivo Formulations May Not Avoid Medicare Negotiations

 
• By Sarah Karlin-Smith

New draft guidance on the third cycle of Medicare drug price negotiations goes against Merck and BMS expectations for their cancer drugs. The guidance also tackles Part B and renegotiated prices for the first time.

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• By Sue Sutter

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