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Will FDA be forced to implement a drug importation program?

July 23, 2019
https-www-hlregulation-com-files-2019-06-pharma-biotech_cells-jpg

What comes out, must go back in: Court sides with FDA on “same surgical procedure” and “homologous use” definitions governing human cell and tissue products

June 6, 2019

CMS proposes requiring drug prices in TV ads

October 23, 2018
prescription

U.S. Senate passes bill requiring prescription drug ads to include prices (updated)

August 28, 2018

FDA Issues Draft Guidance on Requirements for Public Warnings for Recalled Products

January 26, 2018

Unburden Yourself: FDA Requests Comments on Ways to Implement President Trump’s Regulatory Reform Executive Orders

September 8, 2017

Too Much or Too Little: FDA Requests Comments on New Strategy Regarding Risk Information in DTC Ads

August 22, 2017

Short-Fuse Compliance Deadline for Expanded Access Provision in 21st Century Cures Act

December 16, 2016

21st Century Cures Offers More Latitude to Promote Health Care Economic Information, but Ambiguities Would Remain

December 5, 2016

Let’s Get Real: Meredith Manning Urges FDA to Allow Greater Communication of Real World Data Within Its Current Regulatory Framework

November 7, 2016

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Meredith Manning

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