Istituzioni

FDA authorizes marketing of new device designed to remove dead pancreatic tissue

Food and Drug Administration - Me, 23/12/2020 - 23:37
FDA granted de novo for the EndoRotor System to resection (cut out) and remove necrotic (dead) tissue for patients with walled-off pancreatic necrosis.
Categorie: Istituzioni

Coronavirus (COVID-19) Update: December 22, 2020

Food and Drug Administration - Me, 23/12/2020 - 00:03
Coronavirus (COVID-19) Update
Categorie: Istituzioni

FDA Warns Companies Illegally Selling CBD Products

Food and Drug Administration - Ma, 22/12/2020 - 20:35
Today, the FDA issued five warning letters to companies for selling products containing cannabidiol (CBD) in ways that violate the Federal Food, Drug, and Cosmetic Act. All five warning letters address the illegal marketing of unapproved CBD products claiming to treat medical conditions.
Categorie: Istituzioni

Coronavirus (COVID-19) Update: December 21, 2020

Food and Drug Administration - Ma, 22/12/2020 - 00:25
Coronavirus (COVID-19) Update
Categorie: Istituzioni

FDA Takes Additional Action in Fight Against COVID-19 By Issuing Emergency Use Authorization for Second COVID-19 Vaccine

Food and Drug Administration - Sa, 19/12/2020 - 01:29
Today, the FDA issued an emergency use authorization (EUA) for the second vaccine for the prevention of coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The vaccine is for use in individuals 18 years of age and older.
Categorie: Istituzioni

FDA Approves First Adjuvant Therapy for Most Common Type of Lung Cancer

Food and Drug Administration - Ve, 18/12/2020 - 22:49
Today, the FDA approved the first adjuvant treatment for patients with non-small cell lung cancer whose tumors have a specific type of genetic mutation.
Categorie: Istituzioni

FDA Approves Prosthetic Implant for Above-the-Knee Amputations

Food and Drug Administration - Ve, 18/12/2020 - 20:31
FDA approved the Osseoanchored Prostheses for the Rehabilitation of Amputees (OPRA) Implant System, the first implant system in the U.S. for adults with transfemoral amputations and who have or are anticipated to have rehabilitation problems with, or cannot use, a conventional socket prosthesis.
Categorie: Istituzioni

FDA Approves First Oral Hormone Therapy for Treating Advanced Prostate Cancer

Food and Drug Administration - Ve, 18/12/2020 - 18:15
Today, the FDA approved the first oral hormone therapy for treating advanced prostate cancer. This therapy may eliminate some patients’ need to visit the clinic for treatments that require administration by a health care provider.
Categorie: Istituzioni

FDA Statement on Vaccines and Related Biological Products Advisory Committee Meeting

Food and Drug Administration - Ve, 18/12/2020 - 02:36
FDA Statement on Vaccines and Related Biological Products Advisory Committee Meeting
Categorie: Istituzioni

Coronavirus (COVID-19) Update: December 17, 2020

Food and Drug Administration - Ve, 18/12/2020 - 00:24
Coronavirus (COVID-19) Update
Categorie: Istituzioni

Trump Administration Sets the Pace for Food Loss and Waste Reduction Efforts to Continue

Food and Drug Administration - Gi, 17/12/2020 - 22:39
Today, the U.S. Environmental Protection Agency (EPA), U.S. Food and Drug Administration (FDA), and U.S. Department of Agriculture (USDA) announced the renewal of the joint agency formal agreement including the Winning on Reducing Food Waste Initiative.
Categorie: Istituzioni

Actualización sobre el coronavirus (COVID-19): La FDA emite una nueva autorización para la prueba en el hogar BinaxNOW COVID-19 Ag Card

Food and Drug Administration - Gi, 17/12/2020 - 21:20
Hoy, la Administración de Alimentos y Medicamentos de los EE.UU. (FDA, por sus siglas en inglés) emitió una nueva autorización de uso de emergencia (EUA, por sus siglas en inglés) para la prueba realizada en el hogar BinaxNOW COVID-19 Ag Card, que está autorizada para su uso por pacientes en el hoga
Categorie: Istituzioni

FDA Warns Consumers to Avoid Certain Male Enhancement and Weight Loss Products Sold Through Amazon, eBay and Other Retailers Due to Hidden, Potentially Dangerous Drug Ingredients

Food and Drug Administration - Gi, 17/12/2020 - 19:53
FDA is warning consumers not to use nearly 50 male enhancement or weight loss products that have been found to contain hidden ingredients and may pose a significant health risk.
Categorie: Istituzioni

Coronavirus (COVID-19) Update: December 16, 2020

Food and Drug Administration - Gi, 17/12/2020 - 00:16
Coronavirus (COVID-19) Update
Categorie: Istituzioni

FDA Authorizes Marketing of New Implant to Repair a Torn ACL

Food and Drug Administration - Me, 16/12/2020 - 20:32
The FDA granted marketing authorization—under the De Novo premarket review pathway—for the Bridge-Enhanced ACL Repair (BEAR) Implant, an anterior cruciate ligament (ACL) implant intended to serve as an alternative to ACL reconstruction to treat ACL tears.
Categorie: Istituzioni

Coronavirus (COVID-19) Update: FDA Issues New Authorization for the BinaxNOW COVID-19 Ag Card Home Test

Food and Drug Administration - Me, 16/12/2020 - 20:13
Today, the US Food and Drug Administration issued a new emergency use authorization (EUA) for the BinaxNOW COVID-19 Ag Card Home Test to allow individuals to perform the test at home with a prescription.
Categorie: Istituzioni

Coronavirus (COVID-19) Update: FDA Authorizes Antigen Test as First Over-the-Counter Fully At-Home Diagnostic Test for COVID-19

Food and Drug Administration - Ma, 15/12/2020 - 16:53
Today, the U.S. Food and Drug Administration issued an emergency use authorization (EUA) for the first over-the-counter (OTC) fully at-home diagnostic test for COVID-19
Categorie: Istituzioni

Coronavirus (COVID-19) Update: December 14, 2020

Food and Drug Administration - Ma, 15/12/2020 - 00:34
Coronavirus (COVID-19) Update
Categorie: Istituzioni

FDA Approves First-of-its-Kind Intentional Genomic Alteration in Line of Domestic Pigs for Both Human Food, Potential Therapeutic Uses

Food and Drug Administration - Lu, 14/12/2020 - 17:26
FDA approves First-of-its-Kind Intentional Genomic Genomic Alteration (IGA) in an animal for both human food consumption and as a source for potential therapeutic uses.
Categorie: Istituzioni

FDA Takes Key Action in Fight Against COVID-19 By Issuing Emergency Use Authorization for First COVID-19 Vaccine

Food and Drug Administration - Sa, 12/12/2020 - 03:21
Today, the FDA issued the first emergency use authorization (EUA) for a vaccine for the prevention of coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 16 years of age and older.
Categorie: Istituzioni
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