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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 …
Remarks by Dr. Sharpless at the FDA Public Hearing on Scientific Data and Information about Products Containing Cannabis or Cannabis-Derived Compounds - 05/31/2019
… Thank you for joining FDA today for this public hearing titled “Scientific Data and Information About … attendees, and those unable to participate in today’s hearing – to submit comments to our docket on this topic, … group to address these data gaps specifically. You’ll be hearing more from this group in the months to come. FDA is …
Eliminating Youth Electronic Cigarette and Other Tobacco Product Use: The Role for Drug Therapies Public Hearing - 01/18/2019 - 01/18/2019
… Administration (FDA or the Agency) is announcing a public hearing to discuss the effort to eliminate youth electronic … . … Office of the Commissioner … FDA public hearing to discuss the effort to eliminate youth electronic … Tobacco Product Use: The Role for Drug Therapies Public Hearing - 01/18/2019 - 01/18/2019 … E-cigarettes …
FDA Commissioner and Chief Scientist Announce Decision to Withdraw Approval of Makena
… the drug’s approval in 2020. The sponsor requested a hearing, which was held in October 2022. Following the hearing, the FDA Commissioner and Chief Scientist reviewed … public comments to the docket , the transcript of the hearing and the Presiding Officer’s report. Based on that …
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 …
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 …
Better Data for a Better Understanding of the Use and Safety Profile of Cannabidiol (CBD) Products
… of stakeholders interested in CBD. We held a public hearing in May 2019 and issued a call to stakeholders to work … data on CBD. The FDA re-opened the May 2019 public hearing docket , and will keep it open in the future as one …
FDA Widens Scope of Navigator – Information Tool for Expanded Access
… diseases. As I discussed in my testimony at a recent hearing of the Energy and Commerce Committee, expanded access …
FDA Seeks Fines Against 22 Retailers for Selling Illegal Youth-Appealing E-Cigarettes
… an answer to the complaint or file an answer and request a hearing. Those that do not take action within 30 days after …
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 …
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 …
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 …
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 Roundup: December 15, 2023
… decreased neutrophils, increased ALT, increased AST, hearing loss, skin infection, and urinary tract infection. …
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 …
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 Continues Important Work on Substance Use and Overdose Prevention Efforts
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 …