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911 articles found
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Coronavirus (COVID-19) Update: May 25, 2021The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 pandemic:Today, the FDA updated its guidance, Emergency Use Authorizati... -
FDA Announces Seizure of Adulterated Dietary Supplements Containing KratomUPDATE: On October 26, 2021, Judge Sheri Polster Chappell of the United States District Court for the Middle District of Florida entered a consent decree of condemnation and destruction against the a...
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Coronavirus (COVID-19) Update: May 21, 2021The U.S. Food and Drug Administration (FDA) continued to take action in the ongoing response to the COVID-19 pandemic:The FDA issued a reminder to health care providers to give clear, step-by-step ins...
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FDA Approves First Targeted Therapy for Subset of Non-Small Cell Lung CancerToday, the U.S. Food and Drug Administration approved Rybrevant (amivantamab-vmjw) as the first treatment for adult patients with non-small cell lung cancer whose tumors have specific types of genetic...
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FDA In Brief: FDA Solicits Public Feedback on Discussion Paper as Part of its Ongoing Commitment to Patient SafetyThe following is attributed to Jeff Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health “The FDA continues to explore new approaches to promote greater safe...
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FDA In Brief: FDA Alerts Patients and Health Care Providers About Possible Problems with Mammograms Performed at Capitol Radiology LLCThe following quote is attributed to David Lee, M.D., director, Division of Mammography Quality Standards, Office of In Vitro Diagnostics and Radiological Health, FDA’s Center for Devices and R...
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FDA In Brief: FDA Authorizes Longer Time for Refrigerator Storage of Thawed Pfizer-BioNTech COVID-19 Vaccine Prior to Dilution, Making Vaccine More Widely AvailableThe following quote is attributed to Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research Making COVID-19 vaccines widely available is key to getting...
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FDA In Brief: FDA Issues Draft Guidance on Early Clinical Studies for Certain Medical Devices to Improve Glycemic Control for Type 2 DiabetesThe following quote is attributed to Jeff Shuren, M.D., J.D., director of FDA’s Center for Devices and Radiological Health “As part of our commitment to help accelerate the development of i...
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FDA In Brief: FDA Advises Against Use of SARS-CoV-2 Antibody Test Results to Evaluate Immunity or Protection From COVID-19, Including After VaccinationThe following quote is attributed to Tim Stenzel, M.D., Ph.D., director of the Office of In Vitro Diagnostics and Radiological Health in the FDA’s Center for Devices and Radiological Health...
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Coronavirus (COVID-19) Update: May 18, 2021The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 pandemic:On May 17, the FDA provided summary information about the stat...