FDA Direct

• FDA Direct: Catching Up on Agency Reforms

  Listen as we discuss new CDER leadership, how CDER & CBER will collaborate to bring more consistency to reviews, and the action we took on HRT this week.

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  29:58

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  29:58
• FDA Direct: Removing Black Box Warnings for HRT (Part 2/2)

  Practicing doctors share their perspectives on the use of HRT for menopausal women and the FDA's action to remove boxed warnings.

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  42:04

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  42:04
• FDA Direct: Removing Black Box Warnings for HRT (Part 1/2)

  Learn more about why the FDA is initiating label changes for hormone replacement therapy products for menopausal women.

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  1:11:20

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  1:11:20
• FDA Direct: Dramatically lowering drug prices for Americans

  Biologic drugs are incredible, but they’re expensive – and they account for 51% of all drug spending. How can we bring cheaper alternatives to market?

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  20:15

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  20:15
• FDA Direct: Who Buys the Spin — Hook, Line and Sinker?

  It’s amusing when reporters and writers do not have access to FDA information on manufacturing and sterility violations — yet make calls from the peanut gallery.

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  29:39

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  29:39

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