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Statement on FDA’s request for information on requiring fixed-quantity blister packaging for certain opioid pain medicines to help decrease unnecessary exposure to opioids
… included in the configuration. We are also interested in hearing about the potential challenges associated with the …
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 …
Trump Administration Combating Epidemic of Youth E-Cigarette Use with Plan to Clear Market of Unauthorized, Non-Tobacco-Flavored E-Cigarette Products
… — about several issues raised in a recent Congressional hearing regarding JUUL’s outreach and marking practices, …
Statement on new testing results, including low levels of impurities in ranitidine drugs
… are being recalled. We understand the concern we’ve been hearing from parents and pediatricians, and we’ll continue to …
Promoting Effective Drug Development Programs: Opportunities and Priorities for FDA’s Office of New Drugs - 11/07/2019 - 11/07/2019
… or additional policy development. We are interested in hearing specific recommendations for topics where further …
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 takes new action to advance the development of reliable and beneficial genetic tests that can improve patient care
… germline variant information to detect for cardiomyopathy, hearing loss, inborn errors of metabolism and other …
FDA Roundup: December 15, 2023
… decreased neutrophils, increased ALT, increased AST, hearing loss, skin infection, and urinary tract infection. …
Welcoming Remarks to the PIC/S Committee - 09/24/2018
… to welcome you this afternoon and look forward to hearing the outcome of your deliberations. … Office of the …
Remarks by Lowell Schiller, JD at the Council for Responsible Nutrition Conference - 11/7/2019 - 11/07/2019
… about the future, we’re having a broad conversation and hearing the full range of perspectives. To this end, we held … an ingredient is introduced to the market without FDA ever hearing about it, then that undermines the integrity of the …
Advancing Medicinal Nicotine Replacement Therapies as New Drugs – A new step in FDA’s comprehensive approach to tobacco and nicotine
… As the Committee’s first action, we’ve scheduled a public hearing on Jan. 26, 2018, to consider FDA’s Approach to …
Statement on the agency’s actions to tackle the epidemic of youth vaping and court ruling on application submission deadlines for certain tobacco products, including e-cigarettes
… in e-cigarettes quit. This includes holding a public hearing and a separate scientific workshop to discuss efforts …
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 …
FDA, FTC take action to protect kids by citing four firms that make, sell flavored e-liquids for violations related to online posts by social media influencers on their behalf
… in e-cigarettes quit. This includes holding a public hearing and a separate scientific workshop to discuss efforts …
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 warns company marketing unapproved cannabidiol products with unsubstantiated claims to treat cancer, Alzheimer’s disease, opioid withdrawal, pain and pet anxiety
… standards. As part of that work, the FDA held a public hearing in May, and opened a docket for written comments, to …
FDA Roundup: April 14, 2023
… Dairy Foods Association’s (IDFA) request for a public hearing and is issuing a final order to modify the final rule …
Antitrust Concerns and The FDA Approval Process
… on several of the issues that we are discussing at today’s hearing. The FDA public meeting, "Administering the …
FDA Acting Commissioner's Remarks to the 2019 FDLI Annual Conference - 05/02/2019
… I also came prepared. Later today, after lunch, you’ll be hearing from FDA’s top lawyer, Stacy Amin, and I’m sure … in small quantities in blister packaging. You’ll be hearing more about this in the near future. An area I find …
FDA Public Meeting on Responsible Innovation in Dietary Supplements - 05/16/2019
… of Dietary Supplement Programs is looking forward to hearing your suggestions on how we might reshape our …
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 …
Statement by FDA Commissioner Scott Gottlieb, M.D., on balancing access to appropriate treatment for patients with chronic and end-of-life pain with need to take steps to stem misuse and abuse of opioids
… as we continue to confront this crisis. I look forward to hearing the insights from today’s meeting, and will continue …
Remarks from Anna Abram as prepared for delivery to the 2018 Intergovermental Meeting on Drug Compounding
… We are looking forward to your feedback, and also to hearing about your ongoing work on the many facets of …
Remarks by Anna Abram to the 2018 Intergovernmental Meeting on Drug Compounding
… We are looking forward to your feedback, and also to hearing about your ongoing work on the many facets of …
Fall 2018 Unified Agenda: FDA's New Regulatory Work to Advance Health and Safety
… regulations for a new category of over-the-counter hearing aids and the requirements that apply to them; …