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President Waives Section 303 of Defense Act for Essential Meds

President Waives Section 303 of Defense Act for Essential Meds
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United States , Public Health Emergencies , National Security , Office Of Management , Presidential Determination , Waiver Pursuant , Defense Production Act , Essential Medicines , Medical Countermeasures , Executive Order , Combating Public Health Emergencies , Strengthening National Security , Ensuring Essential Medicines , Critical Inputs Are Made ,

"Buy American" Update: Essential Medicines May Continue to Come From Abroad (For Now) | Sheppard Mullin Richter & Hampton LLP


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The Biden Administration has taken (at least temporarily) the teeth out of a Trump-era Executive Order that directed the government to “Buy American” for essential drugs and medical devices. President Trump’s August 2020 Executive Order on Ensuring Essential Medicines, Medical Countermeasures, and Critical Inputs Are Made in the United States (Executive Order 13944) aimed to reduce dependence on foreign drugs and devices critical to the U.S. public health sector, in part by requiring that the U.S. Trade Representative remove those essential items from the coverage of any international free trade agreement. On April 20, 2021, the Biden Administration withdrew just such a proposal to remove essential drugs and medical devices from coverage under the World Trade Organization Government Procurement Agreement (“WTO GPA”). With the proposal withdrawn, the U.S. government remains free to buy U.S.-made ....

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Buy America Update: Essential Medicines May Come From Abroad


Thursday, April 29, 2021
The Biden Administration has taken (at least temporarily) the teeth out of a Trump-era Executive Order that directed the government to “Buy American” for essential drugs and medical devices. President Trump’s August 2020 Executive Order on Ensuring Essential Medicines, Medical Countermeasures, and Critical Inputs Are Made in the United States (Executive Order 13944) aimed to reduce dependence on foreign drugs and devices critical to the U.S. public health sector, in part by requiring that the U.S. Trade Representative remove those essential items from the coverage of any international free trade agreement. On April 20, 2021, the Biden Administration withdrew just such a proposal to remove essential drugs and medical devices from coverage under the World Trade Organization Government Procurement Agreement (“WTO GPA”). With the proposal withdrawn, the U.S. government remains free to buy U.S.-made  ....

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FDA's COVID-19 PREPP Initiative Summary Report — Key Takeaways For Manufacturers


FDA s COVID-19 PREPP Initiative Summary Report — Key Takeaways For Manufacturers
By Madeleine Giaquinto, Manager of Regulatory Affairs, Greenleaf Health, Inc.
In January 2021, as one of his last official acts as the Commissioner of the FDA, Stephen Hahn, M.D., published the
FDA COVID-19 Pandemic Recovery and Preparedness Plan (PREPP) Initiative Summary Report.
1 The PREPP report is the culmination of work performed by the FDA’s PREPP Initiative, which launched in April 2020 to examine lessons learned from the agency’s response spanning FDA policies, processes, operations, communications, and intra-agency coordination to the global COVID-19 pandemic.
2 The FDA asked an independent non-government organization to conduct an objective review of its ongoing COVID-19 response and to summarize findings in the PREPP report. To that end, the third-party organization solicited insights from key FDA staff and external stakeholders, collated lessons learned, ....

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