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FDA takes steps to withdraw approval of the swine drug carbadox due to safety concerns
… approval, CVM must first file a Notice of Opportunity for Hearing, which it issued today. The notice provides the … manufacturer of carbadox with an opportunity to request a hearing on whether the approval should be withdrawn. The company has 30 days to request a hearing. If the company does not request a hearing, the …
FDA approves first telehealth option to program cochlear implants remotely
… Health. A cochlear implant is an implanted electronic hearing device, designed to produce useful hearing sensations to a person with severe to profound hearing loss, by electrically stimulating nerves inside the …
FDA Meetings, Conferences, and Workshops: Past Events
Statement from FDA Commissioner Scott Gottlieb, M.D., on new steps to advance agency’s continued evaluation of potential regulatory pathways for cannabis-containing and cannabis-derived products
… existing authorities. These new steps include: A public hearing on May 31, as well as a broader opportunity for … claims that are aimed at vulnerable populations. Public Hearing The public hearing will give stakeholders an opportunity to provide the …
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 …
FDA In Brief: FDA approval of soy leghemoglobin as a color additive is now effective
… containing objections to the final rule and request for a hearing. Under the law, the effective date of the final rule … not provide any substantive evidence that would justify a hearing or otherwise provide a basis for revoking the … to the regulations. Therefore, the agency is denying the hearing request. The stay of the effective date of the final …
FDA Commissioner and Chief Scientist Announce Decision to Withdraw Approval of Makena
… the drug’s approval in 2020. The sponsor requested a hearing, which was held in October 2022. Following the hearing, the FDA Commissioner and Chief Scientist reviewed … public comments to the docket , the transcript of the hearing and the Presiding Officer’s report. Based on that …
FDA warns JUUL Labs for marketing unauthorized modified risk tobacco products, including in outreach to youth
… about several issues raised in a recent Congressional hearing regarding JUUL’s outreach and marketing practices, … practices that came to light in a recent Congressional hearing. We will continue to scrutinize tobacco product … discussed in testimony from a July 2019 Congressional hearing on JUUL. According to that testimony, a JUUL …
Statement from FDA Commissioner Scott Gottlieb, M.D., on new steps to help prevent new addiction, curb abuse and overdose related to opioid products
… steps today toward these goals. Today, at a Part 15 hearing on this issue, we’re gathering a broad group of … on the delivery system – which brings me back to today’s hearing and why stakeholder feedback is so important. … is critical to our success. That’s why, following the hearing and discussion today, we welcome and strongly …
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 …
Statement from FDA Commissioner Scott Gottlieb, M.D., on new efforts to advance treatment strategies for helping youth addicted to nicotine as a result of the epidemic rise in teen use of e-cigarettes
… related to youth tobacco cessation, we held a public hearing in January on this topic that was invaluable in … of the scientific issues raised during the January public hearing. As part of our efforts to address this issue, we determined that holding both a public hearing and a scientific workshop would provide forums for …
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 …
FDA Roundup: May 09, 2023
… a new web page with details about over-the-counter (OTC) Hearing Aids: What You Should Know before and after buying an OTC hearing aid. COVID-19 testing updates: As of today, 449 …
FDA permits marketing of balloon device to treat persistent Eustachian tube dysfunction
… is the case with ETD, it results in discomfort, impaired hearing, persistent ear infections, ringing in the ears … or other symptoms. “The Eustachian tube supports hearing by maintaining pressure inside the ear,” said Malvina …
FDA is Committed to Sound, Science-based Policy on CBD
… of the issue was center stage at the FDA’s recent public hearing , on May 31st, where the Agency provided stakeholders … of CBD, there were several significant takeaways from the hearing. Several commenters expressed a desire for a … expressed and information shared during the recent public hearing, including new scientific data, and we look forward …
FDA Roundup: August 1, 2023
… violated the 2010 injunction and scheduled an evidentiary hearing regarding whether their noncompliance was justified. Prior to the hearing, the parties negotiated the consent decree, which, …
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 …
FDA Roundup: January 13, 2023
… video about the new category of over-the-counter (OTC) hearing aids, prescription hearing aids, and how they are different from personal sound …
FDA orders Puerto Rico fertility clinic to cease manufacturing immediately for significant violations that pose a danger to health
… has offered the clinic the opportunity for a regulatory hearing. The clinic has five days to request the hearing. Health care professionals and consumers should …
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 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 …
Coronavirus (COVID-19) Update: Federal judge enters temporary injunction against Genesis II Church of Health and Healing, preventing sale of Chlorine Dioxide Products Equivalent to Industrial Bleach to Treat COVID-19
… injunction was not entered and to provide the date for the hearing on the preliminary injunction request. Español A … and Jonathan Grenon until May 1st, 2020. There will be a hearing on the government’s request to extend the injunction …
Public Calendar: September 18-24, 2022
… Date: 09/23/2022 Location: Virtual Subject: Final Rule on Hearing Aids and Related Amendments FDA Participant/Group: … NANDKUMAR; Non FDA Participant/Group: Members of the Hearing Loss Association of America Official Name: Susan T. …