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    Antimicrobial Susceptibility: FDA Launches Test Website, Issues Guidance

    The US Food and Drug Administration (FDA) on Wednesday launched a new website aimed at improving access to information that can help healthcare professionals determine which drugs are most likely to work to treat bacterial or fungal infections. The website is part of an effort mandated by the 21st Century Cures Act to combat rising antimicrobial resistance by providing a central, easily accessible and up-to-date repository for antimicrobial susceptibility interpretive ...
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    FDA Backs Off From Regulating Certain Types of Health Software

    The US Food and Drug Administration (FDA) on Thursday unveiled three guidance documents – two draft and one final – that clarify which types of software will be regulated. One of the draft guidances, the 13-page “ Clinical and Patient Decision Support Software ,” outlines which types of clinical decision support software (CDS), which can compare patient-specific signs with available clinical guidelines to recommend treatments, would no longer be defined as a medic...
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    Woodcock: CDER Informatics System is Top Priority for 2018

    Going into 2018, Janet Woodcock, director of the Center for Drug Evaluation and Research (CDER) at the US Food and Drug Administration (FDA), said that her top priority will be to implement a center-wide informatics system. Woodcock made the comment at the FDA/CMS Summit in Washington, DC on Tuesday, noting that the rest of CDER's priorities for 2018 will be similar to priorities in 2017. Among those are implementing the 21st Century Cures Act ; working toward the goal...
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    Cures Act Implementation: Gottlieb Says Faster Cancer Drug Approvals Coming for Secondary Indications

    US Food and Drug Administration (FDA) Commissioner Scott Gottlieb and NIH Director Francis Collins testified on Thursday before the House Energy & Commerce Committee on how their agencies have worked to implement provisions from the 21st Century Cures Act passed and signed by President Barack Obama a month before he left office. The hearing centered on the mammoth new law that includes major tweaks to how FDA regulates drugs, devices and biologics, and provides ...
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    Study Finds FDA Action on Unapproved Drugs Led to Higher Prices, Longer Shortages

    A new study finds that the US Food and Drug Administration's (FDA) 2006 initiative to get manufacturers selling unapproved drugs to submit the drugs for approval or remove them from the market led to higher prices and longer shortages for those drugs. Background Today, drugs must be reviewed by FDA for safety and efficacy or in some cases conform to an over-the-counter (OTC) monograph before they can be marketed in the US. However, in the years between the 1938 Food, D...
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    Biomarker Qualification: FDA Explains Process and Opportunities for Engagement

    In a set of newly released presentations, officials from the US Food and Drug Administration (FDA) explain changes to the agency's biomarker qualification program and detail early opportunities for biomarker developers to engage with FDA. "A qualified biomarker can be used in multiple drug development programs without the need for [the Center for Drug Evaluation and Research] CDER to reconfirm the suitability of the biomarker's qualified context of use," said Marianne No...
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    FDA Issues Guidance on Informed Consent Waivers for Minimal Risk Studies

    The US Food and Drug Administration (FDA) on Monday issued a final guidance detailing the circumstances in which the agency will not object to waiving or altering informed consent requirements for clinical studies that pose a minimal risk to participants. While the guidance was released without a public consultation on a draft version, FDA says it will consider comments on the final version and revise the guidance as necessary. "Over the years, FDA has received numerous...
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    CDRH Clarifies Process for Consensus Standard Recognition Requests

    The US Food and Drug Administration's (FDA) Center for Devices and Radiological Health (CDRH) this week detailed changes to its process for handling requests for the agency to recognize new voluntary consensus standards for medical devices, as required by the 21st Century Cures Act . Medical device makers often rely on consensus standards in the development and testing of their products, and FDA allows device makers to submit a declaration of conformity to show that the...
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    FDA Finalizes List of 1,003 Class II Device Types Exempt From 510(k) Requirements

    The US Food and Drug Administration (FDA) on Monday finalized a list of 1,003 types of class II medical devices that the agency believes do not present risks that require premarket notification review to provide a reasonable assurance of safety and effectiveness. Established under the 21st Century Cures Act, the list, first published in draft form in March , is part of efforts to decrease regulatory burdens and costs for the device industry. For the complete f...
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    $500m Over 9 Years: FDA Details Plan for New 'Cures' Funds

    The US Food and Drug Administration (FDA) on Friday released a plan submitted to Congress for how it will use $500 million in potential new funding from the 21st Century Cures Act over the next nine fiscal years. The plan, similar to a proposal released in May, would see about $185 million of the total go to updates and modernizing FDA’s regulation of combination products, developing FDA standards and consensus definitions to support the development and revie...
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    FDA Unveils List of Reusable Devices Requiring New Validation Data

    Following superbug outbreaks after issues with reprocessing certain medical devices, the US Food and Drug Administration (FDA) on Thursday released a list of devices that the agency will require validated instructions for use and validation data regarding cleaning, disinfection and sterilization in premarket notification submissions.  The list comes thanks to the 21st Century Cures Act (section 3059), which requires FDA to identify and publish a list of reusable...
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    Senate Democrats to Trump: HHS Cuts Will Impede 'Cures' Implementation

    Eleven Senate democrats sent a letter to President Donald Trump on Tuesday explaining how his proposed cuts in the FY 2018 budget for the Department of Health and Human Services (HHS) will make implementation of the bipartisan 21st Century Cures Act much more difficult. "We urge you to listen to both sides of the aisle and drop any attempts to implement the damaging proposed cuts at HHS laid out in your budget," they wrote. Trump’s budget blueprint for 2018 ...