Food and Drug Administration

Condividi contenuti
Aggiornato: 23 min 47 sec fa

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

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

FDA Authorizes Marketing of Device to Facilitate Muscle Rehabilitation in Stroke Patients

Ven, 23/04/2021 - 16:58
The U.S. Food and Drug Administration has authorized marketing of a new device indicated for use in patients 18 and older undergoing stroke rehabilitation, to facilitate muscle re-education and for maintaining or increasing range of motion.
Categorie: Istituzioni

FDA Approves Immunotherapy for Endometrial Cancer with Specific Biomarker

Gio, 22/04/2021 - 19:02
Today, the FDA approved an immunotherapy for endometrial cancers that have a specific genetic feature known as dMMR which contain abnormalities that affect the proper repair of DNA inside the cell.
Categorie: Istituzioni

FDA Continues Important Steps to Ensure Quality, Safety and Effectiveness of Authorized COVID-19 Vaccines

Mer, 21/04/2021 - 15:15
FDA Continues Important Steps to Ensure Quality, Safety and Effectiveness of Authorized COVID-19 Vaccines
Categorie: Istituzioni

Coronavirus (COVID-19) Update: April 20, 2021

Mar, 20/04/2021 - 21:15
Coronavirus (COVID-19) Update: April 20, 2021
Categorie: Istituzioni

FDA Announces New Streamlined Approach to Add Pooled Serial Screening Claims to Certain Authorized Tests for Use in Serial Testing Programs

Mar, 20/04/2021 - 17:52
FDA announces streamlined EUA amendment for certain molecular test developers to pool specimens as part of a serial testing program.
Categorie: Istituzioni

Coronavirus (COVID-19) Update: FDA Revokes Emergency Use Authorization for Monoclonal Antibody Bamlanivimab

Ven, 16/04/2021 - 22:34
Today, the FDA revoked the emergency use authorization that allowed for the investigational monoclonal antibody therapy bamlanivimab, when administered alone, to be used for the treatment of mild-to-moderate COVID-19 in adults and certain pediatric patients.
Categorie: Istituzioni

Coronavirus (COVID-19) Update: April 16, 2021

Ven, 16/04/2021 - 21:31
Coronavirus (COVID-19) Update: April 16, 2021
Categorie: Istituzioni

FDA Approves First Immunotherapy for Initial Treatment of Gastric Cancer

Ven, 16/04/2021 - 18:01
Today, the FDA approved Opdivo (nivolumab), in combination with certain types of chemotherapy, for the initial treatment of patients with advanced or metastatic gastric cancer, gastroesophageal junction cancer and esophageal adenocarcinoma.
Categorie: Istituzioni

FDA Provides Guidance on Remote Interactive Evaluations for Oversight of Drug Facilities During COVID-19

Mer, 14/04/2021 - 18:48
FDA releases guidance on how remote interactive evaluations will be requested by FDA and conducted for the duration of COVID-19 at drug facilities.
Categorie: Istituzioni

Coronavirus (COVID-19) Update: April 13, 2021

Mar, 13/04/2021 - 19:31
Coronavirus (COVID-19) Update: April 13, 2021
Categorie: Istituzioni

Joint CDC and FDA Statement on Johnson & Johnson COVID-19 Vaccine

Mar, 13/04/2021 - 13:52
Joint CDC and FDA Statement on Johnson & Johnson COVID-19 Vaccine
Categorie: Istituzioni

FDA Authorizes Marketing of First Device that Uses Artificial Intelligence to Help Detect Potential Signs of Colon Cancer

Ven, 09/04/2021 - 23:37
FDA authorized marketing of the GI Genius, the first device that uses artificial intelligence based on machine learning to detect lesions in the colon in real time during a colonoscopy.
Categorie: Istituzioni

Coronavirus (COVID-19) Update: April 9, 2021

Ven, 09/04/2021 - 20:35
The FDA recommends health care personnel and facilities transition from the use of decontaminated disposable respirators, and issues warning letters to two companies for selling unapproved products with fraudulent COVID-19 claims.
Categorie: Istituzioni

FDA Releases Action Plan for Reducing Exposure to Toxic Elements from Foods for Babies, Young Children

Gio, 08/04/2021 - 19:28
FDA Releases Closer to Zero: An Action Plan for Reducing Exposure to Toxic Elements from Foods for Babies and Young Children
Categorie: Istituzioni

FDA Releases Investigation Report Following Fall 2020 Outbreak of E. coli O157:H7 Illnesses Linked to Leafy Greens

Mar, 06/04/2021 - 21:34
FDA publishes investigation report into Fall 2020 outbreak of Shiga Toxin-Producing E. coli (STEC) O157:H7 illnesses linked to the consumption of leafy greens
Categorie: Istituzioni

Coronavirus (COVID-19) Update: April 6, 2021

Mar, 06/04/2021 - 21:02
Coronavirus (COVID-19) Update: April 6, 2021
Categorie: Istituzioni

Coronavirus (COVID-19) Update: FDA Issues Emergency Use Authorization for the Symbiotica COVID-19 Self-Collected Antibody Test System

Mar, 06/04/2021 - 17:02
The U.S. Food and Drug Administration issued an emergency use authorization (EUA) for the Symbiotica COVID-19 Self-Collected Antibody Test System.
Categorie: Istituzioni

Coronavirus (COVID-19) Update: April 2, 2021

Ven, 02/04/2021 - 23:46
Coronavirus (COVID-19) Update: April 2, 2021
Categorie: Istituzioni

Coronavirus (COVID-19) Update: FDA Makes Two Revisions to Moderna COVID-19 Vaccine Emergency Use Authorization to Help Increase the Number of Vaccine Doses Available

Ven, 02/04/2021 - 02:24
The FDA announced two revisions regarding the number of doses per vial available for the Moderna COVID-19 Vaccine.
Categorie: Istituzioni