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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 …
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 …
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, …
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 …
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 …
FDA Insight: Personal Protective Equipment and COVID-19
… and face, hands and arms, head, feet and legs, body, and hearing. Examples include gloves, foot and eye protection, protective hearing, hard hats, respirators, and full body hazmat suits. …
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 …
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 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 …
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 …
FDA Releases Two Discussion Papers to Spur Conversation about Artificial Intelligence and Machine Learning in Drug Development and Manufacturing
… being mindful of potential challenges. We look forward to hearing from experts on this important topic. CDER’s …
Statement on continued efforts to evaluate materials in medical devices to address potential safety questions
… of dental amalgam. We look forward to discussing and hearing feedback on these materials during the November …
FDA and CDC Lift Recommended Pause on Johnson & Johnson (Janssen) COVID-19 Vaccine Use Following Thorough Safety Review
… Practices met today to discuss the latest data on TTS, hearing from the vaccine manufacturer Janssen and the …
FDA Roundup: December 15, 2023
… decreased neutrophils, increased ALT, increased AST, hearing loss, skin infection, and urinary tract infection. …
Patient Perspective Is Vital to FDA's Work
… office is like for someone with a rare disease. By hearing directly from patients and caregivers, review staff …
Highlighting Major Issues Critical to FDA Across Our Diverse Agency After One Year Back
… available, and they have done that well. In the oversight hearing of February 8th, I was able to defend our staff’s …
FDA Insight: Advisory Committee on COVID-19 Vaccines
… >> Anand Shah: Dr. Marks, we're all looking forward to hearing more about the progress being made toward COVID-19 …
Remarks by Commissioner Califf to the 2022 FDLI Annual Conference - 06/14/2022
Remarks by Dr. Woodcock to the Regulatory Education for Industry Conference - 07/19/2021
… time, CBER, are represented at this conference. You’ll be hearing from all three center directors in the plenary …
Remarks by FDA Commissioner Robert M. Califf to the Coalition for Health AI (CHAI) - 03/05/2024
… data as a “one-off” activity. Not surprisingly, I’m hearing that the “effectiveness” metric being used by health …
Remarks by Anna Abram to the Biocom Celebration of Life Dinner - 11/21/2019
… and interchangeable insulin products. We held a public hearing to seek public input on the topic and we have been …