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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 …
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 …
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. …
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 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 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 …
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 Commissioner Califf to the 2022 FDLI Annual Conference - 06/14/2022
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 …