Istituzioni

FDA Approves First Drug to Image Tau Pathology in Patients Being Evaluated for Alzheimer’s Disease

Food and Drug Administration - Gi, 28/05/2020 - 22:22
FDA approved Tauvid for IV injection, the first drug used to help image a distinctive characteristic of Alzheimer’s disease in the brain called tau pathology. Tauvid is a radioactive diagnostic agent for adult patients with cognitive impairment who are being evaluated for Alzheimer’s disease.
Categorie: Istituzioni

Coronavirus (COVID-19) Update: Daily Roundup May 27, 2020

Food and Drug Administration - Gi, 28/05/2020 - 02:34
Coronavirus (COVID-19) Update: Daily Roundup
Categorie: Istituzioni

Coronavirus (COVID-19) Update: FDA Provides New Tool to Aid Development and Evaluation of Diagnostic Tests That Detect SARS-CoV-2 Infection

Food and Drug Administration - Gi, 28/05/2020 - 00:48
FDA new step to support the evaluation of diagnostic tests for COVID-19, by providing a SARS-CoV-2 reference panel. Reference panels are needed to ensure the quality of the tests, validation of new assays, test calibration, and monitoring of assay performance.
Categorie: Istituzioni

FDA Approves Only Drug in U.S. to Treat Severe Malaria

Food and Drug Administration - Me, 27/05/2020 - 02:10
FDA has approved artesunate for injection to treat severe malaria in adult and pediatric patients.
Categorie: Istituzioni

FDA Approves First Treatment for a Form of Bladder Dysfunction in Pediatric Patients as Young as 2 Years of Age

Food and Drug Administration - Me, 27/05/2020 - 00:08
FDA Approves First Treatment for a Form of Bladder Dysfunction in Pediatric Patients as Young as 2 Years of Age
Categorie: Istituzioni

Coronavirus (COVID-19) Update: Daily Roundup May 26, 2020

Food and Drug Administration - Ma, 26/05/2020 - 23:54
Coronavirus (COVID-19) Update: Daily Roundup
Categorie: Istituzioni

Coronavirus (COVID-19) Update: Daily Roundup May 22, 2020

Food and Drug Administration - Ve, 22/05/2020 - 21:38
Coronavirus (COVID-19) Update: Daily Roundup
Categorie: Istituzioni

Coronavirus (COVID-19) Update: Daily Roundup May 21, 2020

Food and Drug Administration - Ve, 22/05/2020 - 00:16
Coronavirus (COVID-19) Update: Daily Roundup
Categorie: Istituzioni

Coronavirus (COVID-19) Update: FDA Provides Promised Transparency for Antibody Tests

Food and Drug Administration - Gi, 21/05/2020 - 20:45
The FDA has posted a list of antibody tests that are no longer being offered under the March 16, 2020 Policy, which is sometimes called the “notification list.”
Categorie: Istituzioni

FDA Releases Report on Investigation into Fall 2019 Outbreaks of Illnesses Tied to Romaine Lettuce

Food and Drug Administration - Gi, 21/05/2020 - 19:44
FDA released the findings of an investigation into the Fall 2019 Outbreaks of Illnesses Tied to Romaine Lettuce
Categorie: Istituzioni

Coronavirus (COVID-19) Update: Daily Roundup May 20, 2020

Food and Drug Administration - Me, 20/05/2020 - 23:07
Coronavirus (COVID-19) Update: Daily Roundup
Categorie: Istituzioni

USDA, FDA Strengthen U.S. Food Supply Chain Protections

Food and Drug Administration - Me, 20/05/2020 - 00:14
The following statement is attributed to Mindy Brashears, Ph.D., USDA Under Secretary for Food Safety, and Frank Yiannas, FDA Deputy Commissioner for Food Policy and Response
Categorie: Istituzioni

Coronavirus (COVID-19) Update: Daily Roundup May 19, 2020

Food and Drug Administration - Ma, 19/05/2020 - 22:49
Coronavirus (COVID-19) Update: Daily Roundup
Categorie: Istituzioni

Coronavirus (COVID-19) Update: FDA Collaborations Promote Rigorous Analyses of Real-World Data to Inform Pandemic Response

Food and Drug Administration - Ma, 19/05/2020 - 16:38
FDA is applying data from diverse sources to inform its response to COVID-19. FDA has entered into an agreement with Aetion to collaborate on advanced analytical techniques to answer urgent COVID-19 research questions.
Categorie: Istituzioni

Coronavirus (COVID-19) Update: Daily Roundup May 18, 2020

Food and Drug Administration - Ma, 19/05/2020 - 00:28
Coronavirus (COVID-19) Update: Daily Roundup
Categorie: Istituzioni

Coronavirus (COVID-19) Update: FDA Authorizes First Standalone At-Home Sample Collection Kit That Can Be Used With Certain Authorized Tests

Food and Drug Administration - Sa, 16/05/2020 - 15:43
FDA informs public about an emergency use authorization for an at-home collection kit for use with multiple authorized COVID-19 diagnostic tests
Categorie: Istituzioni

Coronavirus (COVID-19) Update: Daily Roundup May 15, 2020

Food and Drug Administration - Sa, 16/05/2020 - 00:27
Coronavirus (COVID-19) Update: Daily Roundup
Categorie: Istituzioni

FDA Approves First Drug for Fourth-Line Treatment of Advanced Gastrointestinal Stromal Tumors

Food and Drug Administration - Ve, 15/05/2020 - 21:38
FDA has approved Qinlock (ripretinib) tablets as the first new drug specifically approved as a fourth-line treatment for advanced gastrointestinal stromal tumor (GIST), a type of tumor that originates in the gastrointestinal tract.
Categorie: Istituzioni

Coronavirus (COVID-19) Update: Daily Roundup May 14, 2020

Food and Drug Administration - Ve, 15/05/2020 - 03:16
Coronavirus (COVID-19) Update: Daily Roundup
Categorie: Istituzioni

Coronavirus (COVID-19) Update: FDA Informs Public About Possible Accuracy Concerns with Abbott ID NOW Point-of-Care Test

Food and Drug Administration - Ve, 15/05/2020 - 01:39
FDA informs public about early data that suggest potential inaccurate results from using the Abbott ID NOW point of care test to diagnose COVID-19.
Categorie: Istituzioni
Condividi contenuti