Search Results: FDA

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The Long (Un)Winding Road: FDA Maps Out How the End of the Public Health Emergency Will Impact its COVID-19 Policies

Since the beginning of the COVID-19 pandemic, the United States Food and Drug Administration (“FDA”) has issued more than eighty (80) guidance documents describing flexibilities that would be available to manufacturers of medical devices, drugs and biological products, and foods during the public health emergency.  Several of these guidance documents…

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Leveraging Investigator-Initiated Trials in Rare Disease Drug Development

Investigators interested in rare disease treatment development have the opportunity to approach drug and biologic developers to obtain investigational drug supply for trials in which the investigators, typically at academic institutions, act as sponsor-investigators. Similarly, companies open to extending their product development pipelines can look to investigator-initiated trials as a…

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Congress Expands Pathway for Drug & Device Manufacturers’ Pre-Approval Communication of Health Care Economic Information to Payors, Formularies, & Similar Entities

The legislation previously introduced as the Pre-Approval Information Exchange Act of 2022 (“PIE Act”) was passed as part of Congress’s December 23, 2022 omnibus spending bill. Once signed into law, this legislation will amend the Federal Food, Drug, and Cosmetic Act’s (FDCA’s) provisions on misbranded drugs and devices to formally allow drug…

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USPTO Announces Cancer Moonshot Expedited Examination Program

The U.S. Patent and Trademark Office (“USPTO”) published a Notice in the Federal Register announcing a new pilot program entitled, “Cancer Moonshot Expedited Examination Pilot Program” (the “Cancer Moonshot Program”) (87 Fed. Reg. 75608 (December 9, 2022)) (the “Notice”) to attempt to further accelerate innovation in the health and medical…

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USPTO and FDA Continue to Focus on Patent Quality in the Pharmaceutical Industry

After a recent reminder from the U.S. Patent and Trademark Office (USPTO) regarding the duties of disclosure and reasonable inquiry during examination of a patent application and a Request for Comments (RFC) on the USPTO initiatives to ensure “robustness and reliability” of patent rights,[1] the Director of the U.S. Patent…

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Avoiding Misbranding: Words Matter When Describing the Regulatory Status of 510(k) Cleared Devices and Registered Device Establishments

When it comes to discussing medical devices regulated by the U.S. Food and Drug Administration (FDA), words such as “approved” and “cleared” cannot be used interchangeably as these terms carry a particular meaning. Similarly, creating an impression of approval of a device establishment or its devices because the establishment is…

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FDA Announces Total Product Life Cycle Advisory Program (TAP) Pilot

The U.S. Food and Drug Administration’s (“FDA” or “the Agency”) Center for Devices and Radiological Health (“CDRH”) recently announced the launch of its Total Product Life Cycle Advisory Program (“TAP”) Pilot. The first phase of this voluntary initiative, called TAP Pilot Soft Launch, will be conducted during fiscal year (“FY”)…

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FDA Issues Final Clinical Decision Support Software Guidance

On September 28, 2022, the U.S. Food and Drug Administration (“FDA” or “the Agency”) issued its long-awaited final guidance, “Clinical Decision Support Software” (the “CDS Guidance”). The CDS Guidance follows the Agency’s September 2019 draft guidance of the same name (the “Draft Guidance”) and seeks to clarify several key concepts…

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