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    US Congress Pushes Ahead With Legislation to Reform FDA Voucher Program

    Both the US House of Representatives and Senate are moving forward with identical pieces of legislation meant to overhaul the Neglected Tropical Disease Priority Review Voucher (PRV) system in the hopes of making it more enticing to pharmaceutical companies, and in particular those developing new treatments for the Ebola virus. Bill Background The legislation, the Adding Ebola to the FDA Priority Review Voucher Program Act , would make three notable changes...
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    FDA Expanding Device Program Intended to Make 510(k) Submissions Easier

    The US Food and Drug Administration's (FDA) Center for Devices and Radiological Health (CDRH) is once again expanding an electronic submission pilot program meant to make it substantially easier for companies to create and submit a 510(k) premarket submission to the agency. Background As explained by FDA in May 2014, its new 510(k) eSubmissions Program will help guide companies through the construction and submission of a premarket notification [510(k)] application, "el...
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    FDA Announces Major Regulatory Changes, With Specialization a Key Focus

    Regulatory functions at the US Food and Drug Administration (FDA) are set to undergo a major overhaul in the coming months after a year-long effort by the agency recommended making scores of improvements to the way the agency is structured and regulates products. Background In September 2013, FDA announced to internal staff that, in response to "unparalleled challenges" posed by advances in product complexity and globalization, FDA would be forming a new "Program Alignm...
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    FDA Wants to Make Some of the Most Dangerous Drugs Less of a Burden on Companies and Physicians

    The US Food and Drug Administration (FDA) soon plans to implement four "priority projects" meant to improve its Risk Evaluation and Mitigation Strategies (REMS) programs—a collection of restrictions meant to protect patients from potentially dangerous drug products. Background REMS were first introduced under the 2007 Food and Drug Administration Amendments Act (FDAAA) , and were meant to act as a regulatory hedge against potentially risky products—the answer to the qu...
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    EU Adaptive Licensing Program Moves Forward, With More Clarity for Sponsors

    The European Medicines Agency (EMA) wants to make it easier for companies to use its adaptive licensing pilot program, a new effort to grant accelerated access to medicines intended for limited populations of patients with serious unmet medical needs. Background The adaptive licensing pilot program was first announced in March 2014, and is an attempt to move beyond clear-cut yes-or-no approval dichotomies, and to instead allow some drugs to be approved for limited pop...
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    FDA Review Finds Storage Problems at Food, Supplement Regulator CFSAN

    The US Food and Drug Administration (FDA) has announced that it has found still more vials of improperly stored hazardous substances in one of its labs, just weeks after the agency announced that it had found dozens of other vials of hazardous substances, including the smallpox virus. Background In July 2014, FDA and the National Institutes of Health (NIH) announced they had discovered previously unknown vials containing variola—the virus which causes smallpox—as well...
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    FDA's 'TurboTax' Pilot Program for Medical Devices Expanding

    The US Food and Drug Administration's (FDA) Center for Devices and Radiological Health (CDRH) is expanding a new pilot program that it hopes will make medical device submissions a lot less complicated and a lot more like filing taxes using TurboTax. Background As explained by FDA in May 2014, its new 510(k) eSubmissions Program will help guide companies through the construction and submission of a premarket notification [510(k)] application, "eliminating the need for a ...
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    Pfizer Launches Expanded Access Program for Breast Cancer Drug

    The US Food and Drug Administration's (FDA) expanded access program, sometimes referred to as its "Compassionate Use" program, has frequently been in the news as of late, as dozens of patients have taken to social media in an attempt to pressure companies into allowing them access to clinical trials they believe might save their lives. But while many companies have seemed reluctant to grant access to those trials, pharmaceutical giant Pfizer is taking a markedly differen...
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    New FDA Pilot Program Wants to Make Keeping Track of Device Submissions Simple

    A new early-stage pilot program quietly under development by the US Food and Drug Administration (FDA) hopes to make it easier for medical device companies to see how their device is progressing through the agency's regulatory processes, all at a glance. CDRH Submission Tracker Pilot The Center for Devices and Radiological Health's (CDRH) pilot program, known as the CDRH Submission Tracker pilot, is an attempt to allow companies large and small to have a better sense of...
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    FDA Unveils Pilot Program Aimed at Accelerating Approvals of New Medical Devices

    The US Food and Drug Administration (FDA) is looking for some help from the medical device industry in the hopes of eventually creating a process of faster, more efficient and more predictable approvals. Background Regulators have long been interested in making sure that tools and measures used during the medical device development process are validated -- that is, proper for use and fit for purpose within a specific context. Many clinical trials are ultimately scrapped...
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    FDA Announces First-Ever Approval Under CMS Parallel Review Program

    The US Food and Drug Administration (FDA) and the Centers for Medicare and Medicaid Services (CMS) have jointly approved the first-ever product through a parallel review pilot program that seeks to accelerate the process by which device products obtain government reimbursement decisions. Background The pilot program, known as Parallel Review , was conceived in October 2011 as a way to allow companies to get their products from an investigational stage to reimbursement ...
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    FDA Wants its Regulators to Learn More About 3D Printing, Other Device Topics

    The US Food and Drug Administration (FDA) announced this week that it plans to expand a program it uses to better understand the real-world challenges of the medical device industry it regulates. The ELP Program FDA's Experiential Learning Program (ELP) was announced in September 2011 as part of an ongoing effort to reform the Center for Devices and Radiological Health (CDRH) in light of criticism that the center was too out of touch with challenges faced by device manu...