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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. …
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, …
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 …
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 …
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 …
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 …
Public Meeting on FDA Approach to Evaluating Nicotine Replacement Therapies -
… looking for the information the September 4, 2018 public hearing, please visit “ Facilitating Competition and Innovation in Biological Products Marketplace: Public Hearing ” The Food and Drug Administration (FDA or the Agency) will hold a public hearing on FDA’s approach to evaluating the safety and …
Hemp Production and the 2018 Farm Bill - 07/25/2019
… cannabis products and their derivatives, we held a public hearing on May 31, 2019. The goal of the public hearing was to obtain scientific data and information about … containing cannabis or cannabis-derived compounds. The hearing was attended in person by more than 600 people, with …
Tissue Agnostic Therapies: Regulatory Considerations for Orphan Drug Designation; Public Workshop - 05/09/2018
… A) Silver Spring, MD 20993-0002 The entrance for public hearing participants (non-FDA employees) is through Building … webcast on this page approximately one week after the hearing. A written transcript of the hearing will be made available in the public docket. If you …
Remarks at the National Industrial Hemp Council 2019 Hemp Business Summit - 08/13/2019
… to the legal landscape. And increasingly, we’ve been hearing from a broad range of stakeholders who are eager to … That group has been busy, too. In May, FDA held a public hearing on cannabis issues, including but not limited to CBD. … stakeholders, and the public response was tremendous. The hearing was attended by more than 600 people in person, with …
Remarks by Lauren Silvis, Chief of Staff, to the Consumer Health Products Association Regulatory, Scientific, and Quality Conference - 05/21/2019
… the DFL and labeling are not sufficient. We’re open to hearing from sponsors who want to pursue this approach in the … the regulatory path forward, FDA is holding a public hearing on May 31 to obtain additional scientific data and … related to cannabis and cannabis-derived compounds. This hearing is expected to be an important step in our continued …
Remarks at the Workshop "Packaging, Storage, and Disposal Options to Enhance Opioid Safety - Exploring the Path Forward" - 12/11/2017
… also announcing in the federal register today a public hearing we plan to hold, and a series of questions we intend … potentially harmful drug-drug combinations. The public hearing we’re announcing today in the federal register will … new steps yield meaningful results. I look forward to hearing a summary of what will no doubt be a very important …
Public Meeting on Pediatric Medical Device Development - 08/14/2018
… essential to supporting these efforts. We look forward to hearing from those with a direct stake in this process. So, … continuing engagement on this issue. We look forward to hearing your comments. And we look forward to working closely …
Public Meeting: Optimizing FDA’s Use of and Processes for Advisory Committees - 06/13/2024
… advisory committees, we are interested in more broadly hearing from all parties interested in the advisory committee … and patients may also participate in the open public hearing or submit written comments to the docket for a …
Remarks by Associate Commissioner Mark Abdoo at the Asia-Pacific Economic Cooperation Medical Product Supply Chain Dialogue - 04/25/2023
… ways to incentivize quality manufacturing. You’ll soon be hearing about the Asia Pacific Economic Cooperation’s Roadmap … looks to be an outstanding conference. I look forward to hearing from the next speakers. Thank you. … Office of the …
Remarks at the Joint Public Meeting on the Use of Animal Cell Culture Technology to Develop Products Derived from Livestock and Poultry - 10/23/2018
… strategies to address them. We also look forward to hearing from you on the labeling of these products – both in … in considering these novel technologies. I look forward to hearing your thoughts and concerns today and in the coming …
Remarks on New Strategies for Tobacco Policy and Therapeutic Nicotine Replacement - 12/12/2017
… are used and labeled. FDA has scheduled a public hearing for January 26th to hear from stakeholders on the … related comments to be submitted. The upcoming public hearing is being held to obtain input on the most current … to the marketplace. During the January 26 public hearing, FDA welcomes feedback about public health, …
Final All Hands Meeting with Dr. Gottlieb - 04/04/2019
… times in the past two years. The only major Congressional hearing where I didn’t testify was the one hearing on OTC drug reform where Janet Woodcock told me I …
Pediatric Stakeholder Meeting - A Public Meeting - 11/21/2019
… at the meeting will include, but not be limited to: Hearing from patients/parents and patient/parent groups, …
Examining the Improvements to the Regulation of Medical Technologies -
… access to safe and effective medical devices. Today’s hearing is an important opportunity to explore some of these …