Food and Drug Administration

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

Mar, 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

Lun, 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

Sab, 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

Ven, 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

Ven, 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

Mar, 03/11/2020 - 23:53
Coronavirus (COVID-19) Update
Categorie: Istituzioni

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

Ven, 30/10/2020 - 23:58
Coronavirus (COVID-19) Update
Categorie: Istituzioni

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

Ven, 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

Ven, 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

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

Ven, 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

FDA Publishes List of Essential Medicines, Medical Countermeasures, Critical Inputs Required by Executive Order

Ven, 30/10/2020 - 14:01
A recent executive order directed FDA, in consultation with federal partners, to identify a list of essential medicines, medical countermeasures and critical inputs that are medically necessary to have available at all times in an amount adequate to serve patient needs.
Categorie: Istituzioni

Coronavirus (COVID-19) Update: October 28, 2020

Mer, 28/10/2020 - 22:52
Coronavirus (COVID-19) Update
Categorie: Istituzioni

FDA Approves Lotion for Nonprescription Use to Treat Head Lice

Mar, 27/10/2020 - 20:18
The FDA has approved a lotion to treat head lice for nonprescription, or over-the-counter (OTC), use through a process called a prescription (Rx)-to-OTC switch.
Categorie: Istituzioni

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

Lun, 26/10/2020 - 21:40
Coronavirus (COVID-19) Update: Daily Roundup
Categorie: Istituzioni

Coronavirus (COVID-19) Update: Daily Roundup October 23, 2020

Ven, 23/10/2020 - 22:23
Coronavirus (COVID-19) Update: Daily Roundup
Categorie: Istituzioni

FDA Approves First Treatment for COVID-19

Gio, 22/10/2020 - 21:54
FDA approved the antiviral drug Veklury (remdesivir) for adults and pediatric patients 12 years of age and older for the treatment of COVID-19 requiring hospitalization. Veklury is the first treatment for COVID-19 to receive FDA approval.
Categorie: Istituzioni

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

Mar, 20/10/2020 - 22:35
Coronavirus (COVID-19) Update: Daily Roundup
Categorie: Istituzioni

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

Lun, 19/10/2020 - 22:06
Coronavirus (COVID-19) Update: Daily Roundup of FDA Actions, October 19, 2020
Categorie: Istituzioni

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

Gio, 15/10/2020 - 22:25
The FDA re-issues Emergency Use Authorization for certain filtering facepiece respirators.
Categorie: Istituzioni

FDA Reissues Emergency Use Authorization for Certain Non-NIOSH-Approved Filtering Face-Piece Respirators Manufactured in China

Gio, 15/10/2020 - 21:56
The FDA reissued the Emergency Use Authorization (EUA) for certain filtering face-piece respirators (FFRs) that are manufactured in China and are not approved by the Centers for Disease Control and Prevention’s (CDC) National Institute for Occupational Safety and Health (NIOSH).
Categorie: Istituzioni