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    Video: FDA Commissioner Scott Gottlieb's Keynote Speech at the 2017 Regulatory Convergence

    • 28 September 2017
    US Food and Drug Administration Commissioner Scott Gottlieb addressed attendees of RAPS’ 2017 Regulatory Convergence on 11 September. He focused his remarks on making the clinical end of drug development more efficient and effective . If you missed it or would like to see his presentation again, the video is embedded below.
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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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    MDSAP Update: Canada's 2019 Deadline Still on Track

    Speaking at RAPS' 2017 Convergence on Monday, officials from two international regulators and representatives from auditing organizations offered the latest on the Medical Device Single Audit Program (MDSAP). Background MDSAP is an effort by regulators in the Australia, Brazil, Canada, Japan and the US to establish a single audit process, conducted by recognized third-party auditors, that can meet the requirements of regulators in each country. For manufacturers, MDSAP ...
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    CDRH to Launch 'Critical to Quality' Pilot Program

    The US Food and Drug Administration's (FDA) Center for Devices and Radiological Health (CDRH) will lead a pilot program to define characteristics of a device that are critical to product quality and how these characteristics are controlled in design and manufacturing prior to the postmarket inspection. The voluntary pilot, which will run from 29 September to 31 December 2018, invites firms submitting a Premarket Approval Application (PMA) to consider participating ...
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    Help Wanted: FDA Seeks Digital Health Entrepreneurs

    Details of how the US Food and Drug Administration (FDA) is planning to tackle the growing digital health industry are slowly trickling out, and on Wednesday the agency announced it will establish an Entrepreneur-in-Residence (EIR) Program to support and help develop its Software Precertification (PreCert) Pilot Program. The idea is to embed these entrepreneurs for a minimum of three days per week on FDA’s White Oak campus to help analyze software business processes...
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    Early Feasibility Studies for Devices: FDA Highlights Success From Pilot

    In a paper published in the Journal of Vascular and Interventional Radiology last week, two officials from the US Food and Drug Administration (FDA) say that the agency's early feasibility study (EFS) program helped optimize the development of a new type of catheter designed to prevent pulmonary embolisms. The program is part of an effort by FDA to promote more EFSs being done in the US, as device makers often conduct such studies elsewhere before conducting later stud...
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    Professors Offer 3 Questions on FDA’s New Digital Health Framework

    The US Food and Drug Administration’s (FDA) recent push to reshape how it regulates digital health products with shifts to third-party certification and more postmarket reviews is called into question by three law professors in Health Affairs , who offer up three questions about the direction of the plan. First, the professors from Southern Methodist University, Indiana University and Harvard write that the recently passed 21st Century Cures Act does not includ...
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    FDA Offers More Details on Digital Health Precertification Pilot

    The US Food and Drug Administration (FDA) this week sought to answer some frequently asked questions regarding the rollout of its new precertification pilot program for digital health products, which is expected to begin 1 September and only include nine participating companies. The third-party certification program, first announced in June by FDA Commissioner Scott Gottlieb, will assess developers based on their software development, validation and mai...
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    FDA Updates on Digital Health Plans, Software Pre-Certification Pilot

    The US Food and Drug Administration (FDA) on Thursday released new details on its plans for regulating digital health technologies, including more information about its upcoming pilot program to pre-certify software-based medical devices. According to the agency's newly released Digital Health Innovation Action Plan , FDA's Center for Devices and Radiological Health (CDRH) plans to improve the landscape for digital health technologies by developing guidance on the medic...
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    FDA Launches New ORA Structure to Align Inspections With Expertise

    The US Food and Drug Administration (FDA) on Monday released details on the structure of its newly realigned Office of Regulatory Affairs (ORA). The move, part of FDA's program alignment , is aimed at more closely aligning the agency's inspection efforts with the various products it regulates. "Specializing by FDA-regulated product type more closely mirrors the organizational model of FDA's centers and the industries we regulate," FDA writes. Under the agency's previo...
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    EMA-FDA QbD Pilot Program Led to Further Harmonization

    The European Medicines Agency (EMA) and US Food and Drug Administration (FDA) have wrapped up a joint pilot program assessing applications containing Quality by Design (QbD) elements that led to further hamornization of concepts introduced through the International Council for Harmonisation (ICH). Background The joint pilot program, initially launched in March 2011 for three years, was extended for two more years in 2014 to facilitate further harmonization of per...
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    BIO, AdvaMed Seek to Tweak FDA’s New Pre-Request Draft Guidance for Combo Products

    Industry groups BIO and AdvaMed are seeking some changes to the US Food and Drug Administration’s (FDA) guidance on requesting informal input on combination product designations. Background Under what’s known as the pre-request for designation (pre-RFD) program, sponsors can ask FDA how their product will be classified (drug, device, biological product or combination product), and which of the agency's three review centers will be responsible for reviewing and reg...