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FDA allows marketing of first self-fitting hearing aid controlled by the user
… press-announcements/fda-allows-marketing-first-self-fitting-hearing-aid-controlled-user … The U.S. Food and Drug … today allowed marketing of a new device, the Bose Hearing Aid, intended to amplify sounds for individuals 18 years or older with perceived mild to moderate hearing impairment (hearing loss). This is the first hearing …
FDA takes steps to improve hearing aid accessibility
… /news-events/press-announcements/fda-takes-steps-improve-hearing-aid-accessibility … Español The U.S. Food and Drug … important steps to better support consumer access to hearing aids. The agency issued a guidance document … evaluation or sign a waiver prior to purchasing most hearing aids. This guidance is effective immediately. Today, …
FDA Issues Landmark Proposal to Improve Access to Hearing Aid Technology for Millions of Americans
… s-announcements/fda-issues-landmark-proposal-improve-access-hearing-aid-technology-millions-americans … Español 简体中文 … intended to improve access to and reduce the cost of hearing aid technology for millions of Americans. The agency … rule to establish a new category of over-the-counter (OTC) hearing aids. When finalized, the rule would allow hearing …
Devices Referencing Drugs; Public Hearing; Request for Comments - 11/16/2017
… -conferences-and-workshops/devices-referencing-drugs-public-hearing-request-comments-11162017 … Alert: Change to comment … The Food and Drug Administration is holding a public hearing on a potential approach for certain device sponsors … and legal issues that these products may raise. Hearing Date and Time November 16, 2017 9 a.m. to 5 p.m. …
The FDA engages stakeholders on opportunities to improve hearing aid usage and innovation
… nnouncements/fda-engages-stakeholders-opportunities-improve-hearing-aid-usage-and-innovation … The U.S. Food and Drug … balance patient safety while encouraging advancements in hearing aid technology and access to these devices in the … related to the agency’s premarket requirements for hearing aids and personal sound amplification products …
Scientific Data and Information about Products Containing Cannabis or Cannabis-Derived Compounds; Public Hearing - 05/31/2019 - 05/31/2019
… Background The Food and Drug Administration held a public hearing to obtain scientific data and information about the … Containing Cannabis or Cannabis-Derived Compounds Public Hearing. Transcript Submitting Comments FDA established a docket for public comment on this hearing.The docket number is FDA-2019-N-1482 . On June 20, …
Presentations: FDA's Scientific Data and Information about Products Containing Cannabis or Cannabis-Derived Compounds Public Hearing
… … Part 15 Public Hearing May 31, 2019 Below is a list of participants with … Cannabis or Cannabis-Derived Compounds Part 15 Public Hearing . The presenters are categorized by topic and are … … Presentations from the May 31, 2019 Part 15 public hearing on the FDA's Scientific Data and Information about …
Remarks by Acting Commissioner Ned Sharpless at the FDA Public Hearing on The Future of Biosimilar Insulin - 05/13/2019
… icials/remarks-acting-commissioner-ned-sharpless-fda-public-hearing-future-biosimilar-insulin-05132019 … White Oak, MD … thank you for joining us for today’s very important Public Hearing. The world of public health has never been as … treatments and devices. The subject of today’s public hearing -- facilitating the efficient development of …
Facilitating Price Competition and Innovation in the Biological Products Marketplace Public Hearing - 09/04/2018
… ition-and-innovation-biological-products-marketplace-public-hearing … The Food and Drug Administration (FDA or the Agency) is announcing a public hearing on FDA's approach to enhancing competition and … Administration (FDA or the Agency) is announcing a public hearing on FDA's approach to enhancing price competition and …
Remarks by Dr. Sharpless at the FDA Public Hearing on Scientific Data and Information about Products Containing Cannabis or Cannabis-Derived Compounds - 05/31/2019
… Thank you for joining FDA today for this public hearing titled “Scientific Data and Information About … attendees, and those unable to participate in today’s hearing – to submit comments to our docket on this topic, … group to address these data gaps specifically. You’ll be hearing more from this group in the months to come. FDA is …
Eliminating Youth Electronic Cigarette and Other Tobacco Product Use: The Role for Drug Therapies Public Hearing - 01/18/2019 - 01/18/2019
… Administration (FDA or the Agency) is announcing a public hearing to discuss the effort to eliminate youth electronic … . … Office of the Commissioner … FDA public hearing to discuss the effort to eliminate youth electronic … Tobacco Product Use: The Role for Drug Therapies Public Hearing - 01/18/2019 - 01/18/2019 … E-cigarettes …
Public Hearing on Eliminating Youth Use of Electronic Cigarette and Other Tobacco Product Use: The Role for Drug Therapies - 01/18/2019
… The data and other information presented at today’s hearing will be vitally important to helping the FDA and … by Scott Gottlieb, M.D., FDA Commissioner, at the Public Hearing on Eliminating Youth Use of Electronic Cigarette and … 18, 2019 - Silver Spring, MD … Scott Gottlieb … Public Hearing on Eliminating Youth Use of Electronic Cigarette and …
Remarks from FDA Commissioner Scott Gottlieb, M.D., as prepared for oral testimony before the U.S. House Committee on Energy and Commerce Subcommittee on Oversight and Investigations hearing “Examining U.S. Public Health Preparedness for and Response Efforts to Seasonal Influenza.”
… … Commissioner remarks as prepared for testimony at the hearing “Examining U.S. Public Health Preparedness for and … and Commerce Subcommittee on Oversight and Investigations hearing “Examining U.S. Public Health Preparedness for and …
Public Hearing Presentations: November 16, 2017 Public Hearing on Devices Referencing Drugs
… kshops/public-hearing-presentations-november-16-2017-public-hearing-devices-referencing-drugs … Post-Market Safety … (DRD) Devices Referencing Drugs November 16, 2017 Public Hearing Comment Regarding Devices Proposed for a New Use with … on Devices Referencing Drugs, November 16, 2017 … Public Hearing Presentations: November 16, 2017 Public Hearing on …
Remarks from FDA Commissioner Scott Gottlieb, M.D., as prepared for oral testimony before the House Committee on Energy and Commerce Hearing, “Federal Efforts to Combat the Opioid Crisis: A Status Update on CARA and Other Initiatives
… before the House Committee on Energy and Commerce Hearing, “Federal Efforts to Combat the Opioid Crisis: A … before the House Committee on Energy and Commerce Hearing, “Federal Efforts to Combat the Opioid Crisis: A …
Status of Operations Hearing - 02/27/2019
… /news-events/congressional-testimony/status-operations-hearing-02272019 … Chairman Bishop, Ranking Member … Related Agencies … Scott Gottlieb … Status of Operations Hearing - 02/27/2019 …
Statement from FDA Commissioner Scott Gottlieb, M.D., on the agency’s continued efforts to bring competition to the insulin market to lower prices and expand access
… products. That’s why today we’re announcing a public hearing to discuss access to affordable insulin products, as … and interchangeable insulin products. At the public hearing, we want to hear from stakeholders about what factors … market. Ultimately the input we receive at the public hearing will help to inform steps the FDA can take to advance …
Public Meeting on Facilitating Competition and Innovation in the Biological Products Marketplace - 09/04/2018
… Scott Gottlieb, M.D. Commissioner of Food and Drugs Public Hearing on Facilitating Competition and innovation in the … and thank you for participating in today’s public hearing. Information provided today, and submitted to the … Plan is to learn from stakeholders in today’s public hearing. It’s encouraging to see a diverse set of …
Remarks from FDA Commissioner Scott Gottlieb, M.D., as prepared for oral testimony before the U.S. Senate Committee on Health, Education, Labor & Pensions Hearing, “Implementation of the 21st Century Cures Act: Progress and the Path Forward for Medical Innovation
… committee, thank you for the invitation to testify at this hearing to discuss the implementation of the 21st Century … Senate Committee on Health, Education, Labor & Pensions Hearing, “Implementation of the 21st Century Cures Act: …
The Future of Insulin Biosimilars: Increasing Access and Facilitating the Efficient Development of Biosimilar and Interchangeable Insulin Products - 05/13/2019 - 05/13/2019
… insulin needed to survive. The FDA is holding this public hearing to receive input from stakeholders as the Agency … OMPTFeedback@fda.hhs.gov at least 7 days before the public hearing. Background Information Federal Register notice Final … . … Office of the Commissioner … FDA public hearing to receive input as the Agency prepares for the …
Hearing on an Emerging Disease Threat: How the U.S. Is Responding to COVID-19, the Novel Coronavirus - 03/03/2020 -
… and Pensions Committee, March 3, 2020 … Stephen Hahn … Hearing on an Emerging Disease Threat: How the U.S. Is …
FDA In Brief: FDA takes new steps to help mitigate overprescribing of opioid medications as effort to reduce rates of new addiction
… for opioid prescriber education and holding a public hearing to explore additional frontline measures to curb … for opioid prescriber education and holding a public hearing to explore additional measures to curb …
Remarks from FDA Commissioner Scott Gottlieb, M.D., as prepared for oral testimony before the House Committee on Energy and Commerce Hearing, “Implementing the 21st Century Cures Act: An Update from FDA and NIH"
… before the House Committee on Energy and Commerce Hearing, “Implementing the 21st Century Cures Act: An Update …
Statement from FDA Commissioner Robert Califf, M.D. announcing new draft guidances on medical product communications
… or cleared medical products. The FDA held a Part 15 hearing in November 2016 to hear from a broad range of … for the docket opened in connection with that public hearing for an additional 90 days (until April 19, 2017) to … We have also added a document to the docket for the public hearing titled “ Memorandum: Public Health Interests and …
Statement from FDA Commissioner Scott Gottlieb, M.D., on the agency’s continued efforts to address growing epidemic of youth e-cigarette use, including potential new therapies to support cessation
… to these products. Today, we’re announcing a public hearing , to be held Dec. 5, to discuss our efforts to … the development of such therapies for children. This hearing will also give us an opportunity to discuss the need … health. That the FDA finds that we need to hold such a hearing ‒ to discuss ways to use drug therapies to treat teen …