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Tag: Amy Abernethy

Amy Abernethy

Regulatory/FDA

FDA’s Second Half: Org Changes, Updating Trial Design and Promotional Regulation, 2020 Budget

FDA’s Second Half: Org Changes, Updating Trial Design and Promotional Regulation, 2020 Budget

July 1, 2019 – Among the issues on the Food and Drug Administration’s (FDA’s) plate for the remainder of 2019 are implementing organizational changes, securing appropriations funding for 2020, modernizing clinical trial design and regulating promotional messaging, according to Nancy Bradish Myers, president, Catalyst Healthcare Consulting, who spoke at the recent Coalition for Healthcare Communication […]

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Regulatory/FDA

FDA Leaders Highlight Issues, Opportunities of Real-world Data Post-marketing

FDA Leaders Highlight Issues, Opportunities of Real-world Data Post-marketing

May 6, 2019 — “It doesn’t just take a village, it takes an ecosystem,” Jeffrey Shuren, M.D., J.D., director of the Center for Devices and Radiological Health (CDRH), told the annual meeting of the Reagan-Udall Foundation for the FDA in Washington on May 2, highlighting the challenge of drawing upon a sufficiently broad range of […]

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