Istituzioni

Coronavirus (COVID-19) Update: FDA Authorizes Drug Combination for Treatment of COVID-19

Food and Drug Administration - Gi, 19/11/2020 - 22:26
Today, the FDA issued an emergency use authorization for the drug baricitinib, in combination with remdesivir, for the treatment of COVID-19 in hospitalized adults and pediatric patients 2+ years requiring supplemental oxygen, invasive mechanical ventilation, or ECMO.
Categorie: Istituzioni

FDA Releases New Outbreak Investigation Table

Food and Drug Administration - Me, 18/11/2020 - 21:14
FDA releases new tool to communicate foodborne illness outbreak information frequently and as soon as the FDA begins an outbreak investigation.
Categorie: Istituzioni

Coronavirus (COVID-19) Update: FDA Authorizes First COVID-19 Test for Self-Testing at Home

Food and Drug Administration - Me, 18/11/2020 - 03:29
The FDA issued an emergency use authorization for the first COVID-19 diagnostic test that allows for self-collection and testing at home and provides test results in 30 minutes or less.
Categorie: Istituzioni

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

Food and Drug Administration - Ma, 17/11/2020 - 23:26
Coronavirus (COVID-19) Update
Categorie: Istituzioni

COVID-19 Update: FDA’s Ongoing Commitment to Transparency for COVID-19 EUAs

Food and Drug Administration - Ma, 17/11/2020 - 15:46
FDA is committed to transparency around the EUA process
Categorie: Istituzioni

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

Food and Drug Administration - Ma, 17/11/2020 - 00:02
Coronavirus (COVID-19) Update
Categorie: Istituzioni

FDA Approves First Intratumoral Injection to Treat Non-Metastatic Mast Cell Tumors in Dogs

Food and Drug Administration - Lu, 16/11/2020 - 19:02
FDA approves first intratumoral injection to treat dogs with non-metastatic, skin-based (cutaneous) mast cell tumors (MCTs). The FDA is also approving Stelfonta to treat non-metastatic MCTs located under the dog’s skin (subcutaneous), in particular areas of a dog’s leg.
Categorie: Istituzioni

Coronavirus (COVID-19) Update: November 13, 2020

Food and Drug Administration - Ve, 13/11/2020 - 23:35
Coronavirus (COVID-19) Update
Categorie: Istituzioni

Coronavirus (COVID-19) Update: November 12, 2020

Food and Drug Administration - Ve, 13/11/2020 - 00:13
Coronavirus (COVID-19) Update
Categorie: Istituzioni

Coronavirus (COVID-19) Update: November 10, 2020

Food and Drug Administration - Ma, 10/11/2020 - 23:43
Coronavirus (COVID-19) Update
Categorie: Istituzioni

FDA Encourages Manufacturers to Clearly Declare All Uses of Sesame in Ingredient List on Food Labels

Food and Drug Administration - Ma, 10/11/2020 - 16:22
FDA has issued a draft guidance encouraging food manufacturers to voluntarily declare sesame in the ingredient list on food labels. While most products declare sesame as an ingredient, there are times when sesame is not required to be declared, such as in flavors and spices.
Categorie: Istituzioni

Coronavirus (COVID-19) Update: November 9, 2020

Food and Drug Administration - Ma, 10/11/2020 - 01:16
Coronavirus (COVID-19) Update
Categorie: Istituzioni

Coronavirus (COVID-19) Update: FDA Authorizes Monoclonal Antibody for Treatment of COVID-19

Food and Drug Administration - Ma, 10/11/2020 - 00:12
Today, the FDA issued an emergency use authorization for the investigational monoclonal antibody therapy bamlanivimab for the treatment of mild-to-moderate COVID-19 in adult and pediatric patients.
Categorie: Istituzioni

FDA Offers Guidance to Enhance Diversity in Clinical Trials, Encourage Inclusivity in Medical Product Development

Food and Drug Administration - Lu, 09/11/2020 - 15:45
The FDA has issued final guidance which provides the agency’s current thinking on steps to broaden eligibility criteria in clinical trials through inclusive trial practices. The guidance provides recommendations for how to increase enrollment of underrepresented populations in clinical trials.
Categorie: Istituzioni

FDA Permits Marketing of New Device Designed to Reduce Sleep Disturbance Related to Nightmares in Certain Adults

Food and Drug Administration - Sa, 07/11/2020 - 00:52
FDA has permitted marketing of a new device intended for the temporary reduction of sleep disturbance related to nightmares in adults 22 years or older who suffer from nightmare disorder or have nightmares from post-traumatic stress disorder (PTSD).
Categorie: Istituzioni

Coronavirus (COVID-19) Update: FDA Authorizes First Test that Detects Neutralizing Antibodies from Recent or Prior SARS-CoV-2 Infection

Food and Drug Administration - Ve, 06/11/2020 - 21:05
Today, the U.S. Food and Drug Administration authorized the first serology test that detects neutralizing antibodies from recent or prior SARS-CoV-2 infection.
Categorie: Istituzioni

FDA Takes Efforts to Protect Patients from Potentially Harmful Compounded Drugs Through Finalizing Insanitary Conditions Guidance

Food and Drug Administration - Ve, 06/11/2020 - 16:09
FDA is releasing a final guidance to help compounders identify and prevent insanitary conditions at facilities. The guidance provides recent examples of insanitary conditions and details corrective actions that facilities should take when they identify these conditions.
Categorie: Istituzioni

Coronavirus (COVID-19) Update: November 3, 2020

Food and Drug Administration - Ma, 03/11/2020 - 23:53
Coronavirus (COVID-19) Update
Categorie: Istituzioni

Coronavirus (COVID-19) Update: October 30, 2020

Food and Drug Administration - Ve, 30/10/2020 - 23:58
Coronavirus (COVID-19) Update
Categorie: Istituzioni

FDA, Homeland Security Agencies Take Additional Action to Prevent Import of Illegal and Harmful Medical Products Through International Mail Facilities

Food and Drug Administration - Ve, 30/10/2020 - 21:54
Leadership from the U.S. Food and Drug Administration, the U.S. Customs and Border Protection (CBP), and the U.S. Immigration and Customs Enforcement, Homeland Security Investigations (ICE-HSI) signed a Memorandum of Understanding (MOU) to stop harmful products that pose a threat to public health an
Categorie: Istituzioni
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