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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 …
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 …
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 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, …
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 …
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 …
Statement from FDA Commissioner Scott Gottlieb, M.D., on additional steps by the agency to support the development of safe and effective novel nicotine replacement therapies to help smokers quit cigarettes
… and improve their health. This included holding a public hearing in January 2018 examining the types of safety and … takes into consideration the input received at the public hearing in January 2018 and is intended to serve as a focus …
Coronavirus (COVID-19) Update: Daily Roundup September 23, 2020
… Committee on Health, Education, Labor and Pensions at a hearing entitled, “ COVID-19: An Update on the Federal …
Coronavirus (COVID-19) Update: July 20, 2021
… Committee on Health, Education, Labor and Pensions in a hearing titled, The Path Forward: A Federal Perspective on …
FDA to Hold Advisory Committee Meeting to Discuss Merck and Ridgeback’s EUA Application for COVID-19 Oral Treatment
… regarding the sponsor’s data. There will be an open public hearing during which the public will be given an opportunity …
FDA Roundup: February 17, 2023
… often include mild to moderate intellectual disability, hearing loss, weakened immune system, distinctive facial …
FDA approves first treatment for thyroid eye disease
https://www.fda.gov/news-events/press-announcements/fda-approves-first-treatment-thyroid-eye-disease
… diarrhea, fatigue, hyperglycemia (high blood sugar), hearing loss, dry skin, dysgeusia (altered sense of taste) …
FDA Seeks Fines Against 22 Retailers for Selling Illegal Youth-Appealing E-Cigarettes
… an answer to the complaint or file an answer and request a hearing. Those that do not take action within 30 days after …
FDA Files Civil Money Penalty Complaints Against Four E-Cigarette Product Manufacturers
… answer to the complaint, or file an answer and request a hearing. Companies that do not take action within 30 days …
FDA to Hold Advisory Committee Meetings to Discuss Emergency Use Authorization for Booster Doses and COVID-19 Vaccines for Younger Children
… of the manufacturers’ data. There will be an open public hearing each day during which the public will be given an …
FDA Proposes New Requirements for Tobacco Product Manufacturing Practices
… meet specifications. The FDA will hold a public oral hearing on April 12 to gather additional comments from …
FDA to Hold Listening Session as Part of Broader Work to Optimize Use of, and Processes for, Advisory Committees
… on a committee. Additionally, the agency is interested in hearing about how it could improve the public’s awareness and …
Coronavirus (COVID-19) Update: FDA Continues User-Fee Related Reviews Through COVID-19
… on incoming submissions moving forward. We are seeing and hearing from industry that companies are taking a role as …
Statement from Sarah Yim, M.D., acting director of the Office of Therapeutic Biologics and Biosimilars in the FDA’s Center for Drug Evaluation and Research, on FDA’s continued progress facilitating competition in the biologic marketplace with approval of 25th biosimilar product
… in safety and effectiveness. The FDA held a public hearing on the development of biosimilar and interchangeable …
FDA Roundup: May 10, 2024
… the FDA provided information on how to safely charge hearing aids, glucose monitors, insulin pumps, and other …
Coronavirus (COVID-19) Update: Federal judge enters temporary injunction against Xephyr LLC doing business as N-Ergetics, preventing sale of Colloidal Silver Products for COVID-19
… The Order expires on June 4, 2020. There will be a hearing on the government’s request to extend the injunction …
Statement on the agency’s efforts to protect patients from potentially harmful drugs sold as homeopathic products
… draft guidance, and information gleaned from a 2015 public hearing on the current use of homeopathic drug products. When …
FDA Issues Recommendations for Certain High-Risk Groups Regarding Mercury-Containing Dental Amalgam
… health outcomes. We have made these recommendations after hearing from health care professionals, evaluating published …