Search
Coronavirus (COVID-19) Update: Daily Roundup May 29, 2020
… FDA MyStudies app available to investigators as a free platform to securely obtain patients’ informed consent … that give off electronic radiation, and for regulating tobacco products. … Office of the Commissioner … Coronavirus …
Public Calendar: August 22-28, 2021
… Name: Mitchell R. Zeller, J.D., Director, Center for Tobacco Products No Significant Event Official Name: Steven …
2020 Report on Scientific Conferences With Expenses Over $30,000
… in its negotiations of the Trans-Pacific Partnership Free Trade Agreement and the Transatlantic Trade and … infrastructure, disease control, international health, and tobacco control. General description of the scientific … Cooperation Centre for Scientific Research Relative to Tobacco - Smoke Techno Conference Applicable Conference …
Public Calendar: November 12-18, 2023
… Official Name: Brian King, Ph.D., Director, Center for Tobacco Products Event Date: 11/15/2023 Location: Virtual … Several representatives from the National Association of Tobacco Outlets (NATO) Official Name: Tracey H. Forfa, J.D., …
FDA Approves First-Line Immunotherapy for Patients with MSI-H/dMMR Metastatic Colorectal Cancer
… a statistically significant improvement in progression-free survival (PFS) as assessed by blinded independent … that give off electronic radiation, and for regulating tobacco products. … Office of the Commissioner … FDA …
Public Calendar: July 16-22, 2023
… Official Name: Brian King, Ph.D., Director, Center for Tobacco Products Event Date: 07/18/2023 Location: Virtual … FDA Participant/Group: Several representatives from Smoke Free Alternatives Trade Association (SFATA) Official Name: …
FDA Approves First Adjuvant Therapy for Most Common Type of Lung Cancer
… to come back or for death to occur from any cause (disease-free survival). In the overall trial population, patients who … that give off electronic radiation, and for regulating tobacco products. … Office of the Commissioner … Today, the …
FDA Approves First Targeted Treatment for Patients with Cholangiocarcinoma, a Cancer of Bile Ducts
… trial demonstrating an improvement in progression-free survival or overall survival as a postapproval … that give off electronic radiation, and for regulating tobacco products. … Office of the Commissioner … FDA has …
FDA to Hold Listening Session as Part of Broader Work to Optimize Use of, and Processes for, Advisory Committees
… of drugs, biological products, medical devices and tobacco products, as well as broader scientific, medical and … on June 13 from 9 a.m. to 4 p.m. ET. To register for the free public meeting, please visit the FDA’s website . Input …
FDA In Brief: FDA advances three important initiatives to support medical device development, innovation and safety
… us to more efficiently detect potential safety issues and free up resources to better focus on addressing the highest … that give off electronic radiation, and for regulating tobacco products. … Office of the Commissioner … FDA meets …
FDA Approves New Therapy for Patients with Previously Treated Multiple Myeloma
… The efficacy of Sarclisa was based on progression-free survival (PFS) – the amount of time a patient stays … that give off electronic radiation, and for regulating tobacco products. … Office of the Commissioner … FDA approved …
Public Calendar: December 17-23, 2023
… Swanson (The Arc/Project TENDR); Liz Hitchcock (Toxic-Free Future); Brian Ronholm, Michael Hansen (Consumer … Official Name: Brian King, Ph.D., Director, Center for Tobacco Products No Significant Event Official Name: Tracey …
FDA Approves First Drug for Fourth-Line Treatment of Advanced Gastrointestinal Stromal Tumors
… to receive placebo, to determine whether progression free survival (PFS) – the time from initial treatment in the … that give off electronic radiation, and for regulating tobacco products. … Office of the Commissioner … FDA has …
Coronavirus (COVID-19) Update: FDA Provides More Regulatory Relief During Outbreak, Continues to Help Expedite Availability of Diagnostics
… extraction kits, swabs and more. We’ve also set up a toll-free line, 1-888-INFO-FDA, to help labs with any questions … that give off electronic radiation, and for regulating tobacco products. … Office of the Commissioner … Coronavirus …
FDA Roundup: October 27, 2023
… of news from around the agency: Today, the FDA Center for Tobacco Products (CTP) Director Brian King published a …
Coronavirus (COVID-19) Update: FDA Continues to Facilitate Access to Crucial Medical Products, Including Ventilators
… of reagents, extraction kits, swabs and more. The toll-free line, 1-888-INFO-FDA, is in place to help laboratories … that give off electronic radiation, and for regulating tobacco products. … Office of the Commissioner … Coronavirus …
Statement on agency’s efforts to increase transparency in medical device reporting
… the FDA to efficiently detect potential safety signals and free up resources to better focus on addressing the highest … that give off electronic radiation, and for regulating tobacco products. … Office of the Commissioner … The FDA is …
Remarks by Commissioner Robert M. Califf to the Food is Medicine National Summit: “Transforming Health Care” - 04/26/2023
… and the American Academy of Pediatrics, we’ve created free programs in nutrition and food safety. For example, we … We see this across the spectrum -- from continuing use of tobacco products or vaping, to spurning effective and …
Remarks at the National Industrial Hemp Council 2019 Hemp Business Summit - 08/13/2019
… dietary supplements; animal foods; cosmetics; and tobacco products. We’re also responsible for some other … At the same time, we also know that CBD is not a risk-free substance. As with many drugs, there are potential … patients 2 years of age and older. Epidiolex is not risk-free, but FDA determined that when the drug is used for these …
FDA Statement on the FDA’s ongoing investigation into valsartan and ARB class impurities and the agency’s steps to address the root causes of the safety issues
… ensure that active ingredients and finished products are free of detectable levels of a nitrosamine impurities … that give off electronic radiation, and for regulating tobacco products. … Office of the Commissioner … FDA …
Statement from FDA Commissioner Scott Gottlieb, M.D., and Director of FDA’s Center for Drug Evaluation and Research Janet Woodcock, M.D., on the FDA’s continuing efforts to maintain its strong oversight of generic drug quality issues domestically and abroad
… our programs. We welcome the accountability inspired by a free press. This dialogue is part of how we advance our … that give off electronic radiation, and for regulating tobacco products. … Office of the Commissioner … FDA outlines …
Harnessing the Potential of Artificial Intelligence
… or digital health technologies, for example. We can free up staff by automating repetitive administrative … … Medical Devices … Radiation-Emitting Products … Tobacco … Harnessing the Potential of Artificial Intelligence …
Remarks by Dr. Woodcock to the RAPS (Regulatory Affairs Professionals Society) 2021 Convergence Conference - 09/12/2021
… Also, as many of you know, we have been engaged in user free negotiations across a number of programs. Fortunately … … Biologics … Drugs … Food & Beverages … Medical Devices … Tobacco … Janet Woodcock … Remarks by Dr. Woodcock to the …
Remarks by Commissioner Robert Califf to the National Consumer League Health Advisory Council Winter Meeting - 11/29/2023
… Supplements … Drugs … Food & Beverages … Medical Devices … Tobacco … Robert Califf … Remarks by Commissioner Robert …
FDA's “All-in” Approach to Enterprise Transformation
… … Medical Devices … Radiation-Emitting Products … Tobacco … FDA's “All-in” Approach to Enterprise Transformation …