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Cold Indication For Antihistamine Monograph Expected This Year – DNDP Director Michele

 
• By Eileen Francis

FDA this year will publish an antihistamine monograph rule stemming from a partnership with Canada, says Theresa Michele, director of the Division of Nonprescription Drug Products. At a recent CHPA conference, Michele suggested FDA will parlay strong momentum and internal improvements from 2015 into 2016 progress.

FDA expects to maintain momentum from 2015 with rulemakings in 2016 on OTC antihistamines and antiseptics while making progress on a proposed rule on cough and cold product labeling, says OTC drug program head Theresa Michele.

Speaking during an FDA leadership panel at the Consumer Healthcare Products Association Regulatory, Scientific & Quality Conference in Rockville, Md

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More from United States

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The first two classes of negotiated drugs under the Inflation Reduction Act would not benefit from a rare disease adjustment House Republicans included in their reconciliation package.

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Medicare Negotiation Does Not Violate Due Process, Appeals Court Rules, Other Suits At Risk

 
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More from North America

Keep Talking: US FDA’s Beleaguered Biologics Center Remains Vital To Regenerative Medicine

 
• By Bridget Silverman

Advisory committee for Capricor’s deriamocel planned, regenerative medicine advanced therapy designations proliferate for osteoarthritis, and the ranks of dual RMAT/breakthrough therapy designation holders grow.

Pink Sheet Podcast: A New Director For US FDA’s Biologics Center, Guidance Production Slowdowns

 
• By Derrick Gingery, Sue Sutter, and Nielsen Hobbs

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• By Sue Sutter and Derrick Gingery

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