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The Defense Production Act: An Important National Security Tool, But It Requires Work

The Defense Production Act (DPA) of 1950 lies at a unique nexus between private industry and federal investment for the purposes of national security. Despite its demonstrable utility, modifications to the lawโ€™s implementation are necessary. The DPA should be more narrowly focused on national defense and avoid intervention in areas that do not fall within a strict concept of national security. Congress must provide sufficient appropriations for the Title III Fund to adequately address vulnerab...
White House District Of Columbia United States North Korea Government Printing Office Harry Truman

New FDA Guidance Clinical Trial Considerations To Support Accelerated Approval Of Oncology Therapeutics

On April 6, 2023, AbbVie announced that it was voluntarily withdrawing ibrutinib, which was granted accelerated approval for two indications: mantle...
Marjoriee Zettler Oncologic Drugs Advisory Committee Drug Administration Us Government Accountability Office Drug Administration Accelerated Approval Of Malignant Hematology Oncology Center

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FDA Issues Implementation Guidance on Cybersecurity Requirements for Medical Device Premarket Submissions | Nelson Mullins Riley & Scarborough LLP

The U.S. Food and Drug Administration (FDA or the Agency) has issued guidance concerning cybersecurity requirements for certain medical device premarket submissions (the Guidance). The...
Paul Clowes Nelson Mullins Riley Scarborough Product Development Protocols Pdps Drug Administration Nelson Mullins Riley Federal Food

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