Food and Drug Administration

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Coronavirus (COVID-19) Update: May 14, 2021

Ven, 14/05/2021 - 22:18
Coronavirus (COVID-19) Update: May 14, 2021
Categorie: Istituzioni

FDA In Brief: FDA Releases Investigation Report Following 2020 Salmonella Outbreak Linked to Red Onions

Gio, 13/05/2021 - 21:09
Today, the FDA released a 2020 Salmonella Outbreak Report that includes an overview of our traceback, on-site investigation, and various factors that potentially contributed to the contamination of red onions with Salmonella.
Categorie: Istituzioni

FDA In Brief: FDA Continues to Monitor the Effects of Magnets in Consumer Electronics on Implanted Medical Devices

Gio, 13/05/2021 - 20:09
FDA is advising the public that electronic devices, such as certain cell phones and smart watches, have high field strength magnets capable of placing medical devices in their “magnet mode.” These magnets can affect normal operations of the medical device until the magnetic field is moved.
Categorie: Istituzioni

Coronavirus (COVID-19) Update: May 11, 2021

Mar, 11/05/2021 - 22:54
Coronavirus (COVID-19) Update
Categorie: Istituzioni

FDA In Brief: FDA Finalizes Guidance with Internationally Harmonized Recommendations to Further Support Safe, High-Quality Human Drug Products

Mar, 11/05/2021 - 15:56
FDA finalizes guidance to discuss how to identify the elements in an application that are considered necessary to assure product quality.
Categorie: Istituzioni

Coronavirus (COVID-19) Update: FDA Authorizes Pfizer-BioNTech COVID-19 Vaccine for Emergency Use in Adolescents in Another Important Action in Fight Against Pandemic

Lun, 10/05/2021 - 23:05
The FDA expanded the emergency use authorization (EUA) for the Pfizer-BioNTech COVID-19 Vaccine for the prevention of coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) to include adolescents down to 12 years of age.
Categorie: Istituzioni

FDA In Brief: FDA to Hold Meeting of its Vaccines and Related Biological Products Advisory Committee to Discuss Pediatric Use of COVID-19 Vaccines

Lun, 10/05/2021 - 18:12
The FDA will convene a virtual meeting of the Vaccines and Related Biological Products Advisory Committee (VRBPAC) on June 10, 2021, to discuss pediatric use of COVID1-9 vaccines.
Categorie: Istituzioni

Coronavirus (COVID-19) Update: May 7, 2021

Ven, 07/05/2021 - 21:15
Coronavirus (COVID-19) Update: May 7, 2021
Categorie: Istituzioni

FDA In Brief: FDA Issues Procedural Notice on Potential Plans to Conduct Research About Use of ‘Healthy’ Symbols on Food Products

Gio, 06/05/2021 - 15:53
FDA In Brief: FDA Issues Procedural Notice on Potential Plans to Conduct Research About Use of ‘Healthy’ Symbols on Food Products.
Categorie: Istituzioni

Coronavirus (COVID-19) Update: FDA Outlines Inspection and Assessment Activities During Pandemic, Roadmap for Future State of Operations

Mer, 05/05/2021 - 19:10
FDA issued a new report outlining the agency’s inspectional activities during the COVID-19 pandemic and its detailed plan to move toward a more consistent state of operations.
Categorie: Istituzioni

Coronavirus (COVID-19) Update: May 4, 2021

Mar, 04/05/2021 - 21:45
Coronavirus (COVID-19) Update: May 4, 2021
Categorie: Istituzioni

Coronavirus (COVID-19) Update: April 30, 2021

Ven, 30/04/2021 - 22:57
Coronavirus (COVID-19) Update: April 30, 2021
Categorie: Istituzioni

La FDA se compromete a tomar medidas basadas en la evidencia dirigidas a salvar vidas y prevenir futuras generaciones de fumadores

Ven, 30/04/2021 - 22:53
La FDA se compromete a avanzar en el desarrollo de dos estándares para productos de tabaco y reducir significativamente las enfermedades y muertes por el uso de productos de tabaco, la principal causa de fallecimientos evitables en los EE. UU.
Categorie: Istituzioni

FDA Approves Treatment for Chronic Kidney Disease

Ven, 30/04/2021 - 22:25
Today, the FDA approved a treatment to reduce the risk of kidney function decline, kidney failure, cardiovascular death and hospitalization for heart failure in adults with chronic kidney disease who are at risk of disease progression.
Categorie: Istituzioni

FDA Approves Higher Dosage of Naloxone Nasal Spray to Treat Opioid Overdose

Ven, 30/04/2021 - 15:21
FDA approves a higher dose naloxone nasal spray product to treat opioid overdose. The newly approved product delivers 8 milligrams (mg) of naloxone into the nasal cavity.
Categorie: Istituzioni

FDA Commits to Evidence-Based Actions Aimed at Saving Lives and Preventing Future Generations of Smokers

Gio, 29/04/2021 - 15:45
FDA commits to advancing two tobacco product standards to significantly reduce disease and death from using combusted tobacco products, the leading cause of preventable death in the U.S.
Categorie: Istituzioni

FDA Takes Action For Failure to Submit Required Clinical Trial Results Information to ClinicalTrials.Gov

Mer, 28/04/2021 - 18:52
FDA Issued a Notice of Noncompliance For Failure to Submit Required Clinical Trial Results Information to ClinicalTrials.Gov
Categorie: Istituzioni

Coronavirus (COVID-19) Update: April 27, 2021

Mar, 27/04/2021 - 21:03
Coronavirus (COVID-19) Update: April 27, 2021
Categorie: Istituzioni

FDA and CDC Lift Recommended Pause on Johnson & Johnson (Janssen) COVID-19 Vaccine Use Following Thorough Safety Review

Sab, 24/04/2021 - 00:56
Following a thorough safety review, the U.S. Food and Drug Administration and the U.S. Centers for Disease Control and Prevention have determined that the recommended pause regarding the use of the Johnson & Johnson (Janssen) COVID-19 Vaccine in the U.S. should be lifted.
Categorie: Istituzioni

Coronavirus (COVID-19) Update: April 23, 2021

Ven, 23/04/2021 - 21:52
Coronavirus (COVID-19) Update: April 23, 2021
Categorie: Istituzioni