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Statement by FDA Commissioner Scott Gottlieb, M.D., on FDA’s new steps to help produce farmers, processors more effectively comply with food safety requirements
… of the FSMA implementation process. And we’re committed to hearing all perspectives. Our aim is to ensure that the …
FDA Roundup: January 31, 2023
… (MDUFA) V, Device Innovation, Over-the-Counter (OTC) Hearing Aid Final Rule, and Device Safety. On Thursday, the …
FDA Announces Key FSMA Rule to Advance Traceability of Foods, A Major Milestone in the New Era of Smarter Food Safety
… compatible with those standards. We look forward to hearing comments on the proposed rule, including perspectives …
Statement from FDA Commissioner Scott Gottlieb, M.D., on ongoing efforts to mitigate impact of saline shortages during this flu season
… products, such as the empty IV containers. We are also hearing from some health care providers that there are spot …
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 …
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. …
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 …
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 …
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 …
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 …
Results from 2018 National Youth Tobacco Survey show dramatic increase in e-cigarette use among youth over past year
… the nation. The FDA also recently announced a public hearing , to be held Dec. 5, to discuss efforts to eliminate …
FDA Advances Work Related to Cannabidiol Products with Focus on Protecting Public Health, Providing Market Clarity
… the public docket we established for our May 2019 public hearing. The docket provides a valuable conduit for …
Statement from FDA Commissioner Scott Gottlieb, M.D., on launch of ‘The Real Cost’ Youth E-Cigarette Prevention Campaign amid evidence of sharply rising use among kids
… I want to support these trends. But more and more I’m hearing from parents of kids who are addicted – telling me …
Statement from FDA Commissioner Scott Gottlieb, M.D., on new data demonstrating rising youth use of tobacco products and the agency’s ongoing actions to confront the epidemic of youth e-cigarette use
… in e-cigarettes quit. This includes holding a public hearing to discuss efforts to eliminate youth e-cigarette use …
Statement from FDA Commissioner Scott Gottlieb, M.D., on the agency’s new efforts to strengthen regulation of dietary supplements by modernizing and reforming FDA’s oversight
… confidence in the entire industry. We’re interested in hearing other ideas our stakeholders may have, and not just …
Statement from FDA Commissioner Scott Gottlieb, M.D., on new actions advancing the agency’s biosimilars policy framework
… biosimilar development programs ongoing. We held a Part 15 hearing in September, to hear from the community how we can …
Statement from FDA Commissioner Scott Gottlieb, M.D., on proposed new steps to protect youth by preventing access to flavored tobacco products and banning menthol in cigarettes
… But as I said at that time, as I said at my confirmation hearing, as I said in my first remarks to the professional …