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FDA Enhances Global Patient and Regulatory Collaborations in Oncology
… centered drug development is key, and we look forward to hearing from patients, investigators, and regulators at the …
Public Calendar: April 9-15, 2023
… Date: 04/12/2023 Location: Virtual Subject: Public Oral Hearing on Proposed New Requirements for Tobacco Product …
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 in Brief: FDA updates label for Chantix with data underscoring it’s not effective in children 16 and younger
… from the dangers of tobacco use, the FDA held a public hearing in January to discuss the effort to eliminate youth …
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 approves a new antibacterial drug to treat a serious lung disease using a novel pathway to spur innovation
… (difficulty speaking), cough, ototoxicity (damaged hearing), upper airway irritation, musculoskeletal pain, …
FDA approves pill with sensor that digitally tracks if patients have ingested their medication
… years of age. Symptoms of those with schizophrenia include hearing voices, believing other people are reading their …
Public Calendar: March 27 - April 2, 2022
… Washington, DC Subject: FDA User Fee Reauthorization Hearing: Ensuring Safe and Effective Medical Devices FDA …
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 …
Trump Administration Launches “Winning on Reducing Food Waste” Initiative
… out the event. The agencies collectively look forward to hearing feedback from stakeholders about how they can work …
FDA In Brief: FDA proposes improvements to the De Novo pathway for novel medical devices to advance safe, effective, and innovative treatments for patients
… FDA granted in 2017 and 2018, were the first self-fitting hearing aid , the first mobile app to help treat substance …
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 …
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 …
Addressing Needs of Patients While Stemming the Tide of the Opioid Crisis
… addiction. Not a day goes by in my role at FDA without hearing stories of the emotional, physical, and financial …
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 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 …
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 …
Statement from FDA Commissioner Scott Gottlieb, M.D., about crops impacted by Hurricanes Harvey and Irma and FDA’s work with farmers affected by the storms
… American farmers who have suffered crop losses. You’ll be hearing a lot from us in the coming weeks, as we do our part …
Statement on efforts to help make development of biosimilar and interchangeable insulin products more efficient
… stakeholder feedback provided at the FDA’s May 2019 public hearing on this topic at which stakeholders were invited to …
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 …