Istituzioni

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

Food and Drug Administration - Mar, 20/10/2020 - 23:35
Coronavirus (COVID-19) Update: Daily Roundup
Categorie: Istituzioni

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

Food and Drug Administration - Lun, 19/10/2020 - 23:06
Coronavirus (COVID-19) Update: Daily Roundup of FDA Actions, October 19, 2020
Categorie: Istituzioni

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

Food and Drug Administration - Gio, 15/10/2020 - 23:25
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

Food and Drug Administration - Gio, 15/10/2020 - 22:56
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

FDA Warns that Using a Type of Pain and Fever Medication in Second Half of Pregnancy Could Lead to Complications

Food and Drug Administration - Gio, 15/10/2020 - 21:00
Today, FDA issued a Drug Safety Communication announcing label changes that limit the use of pain-relieving and fever-reducing nonsteroidal anti-inflammatory drugs (NSAIDs) after around 20 weeks gestation or later in pregnancy.
Categorie: Istituzioni

FDA Approves First Treatment for Ebola Virus

Food and Drug Administration - Mer, 14/10/2020 - 22:35
Today, the FDA approved Inmazeb, a mixture of three monoclonal antibodies, as the first FDA-approved treatment for Zaire ebolavirus (Ebola virus) infection in adult and pediatric patients.
Categorie: Istituzioni

Coronavirus (COVID-19) Update: Daily Roundup October 13, 2020

Food and Drug Administration - Mar, 13/10/2020 - 22:53
The FDA issues and implements new guidance regarding molecular influenza and RSV tests.
Categorie: Istituzioni

FDA Warns Dietary Supplement Companies Illegally Selling Products Containing Cesium Chloride

Food and Drug Administration - Mar, 13/10/2020 - 22:17
FDA has posted five warning letters issued to companies marketing dietary supplements containing cesium chloride. FDA will continue to take action against dietary supplements that contain cesium chloride because of significant safety concerns.
Categorie: Istituzioni

Coronavirus (COVID-19) Update: Daily Roundup October 9, 2020

Food and Drug Administration - Ven, 09/10/2020 - 22:42
The FDA and the Federal Trade Commission issue warning letters for selling fraudulent COVID-19-related products.
Categorie: Istituzioni

Coronavirus (COVID-19) Update: Daily Roundup October 8, 2020

Food and Drug Administration - Gio, 08/10/2020 - 22:26
The FDA updates dashboard on the Coronavirus Treatment Acceleration Program (CTAP) webpage.
Categorie: Istituzioni

FDA awards six grants to fund new clinical trials to advance the development of medical products for the treatment of rare diseases

Food and Drug Administration - Gio, 08/10/2020 - 17:20
FDA announced awards for six new clinical trial research grants totaling over $16 million over the next four years. The grants, awarded through the Congressionally-funded Orphan Products Grants Program, enhance the development of medical products for patients with rare diseases.
Categorie: Istituzioni

FDA Reaffirms Commitment to Safety, Security of its Public Health Laboratories

Food and Drug Administration - Gio, 08/10/2020 - 16:49
FDA’s mission to protect and promote public health has always relied on a rigorous analysis of the scientific data available and we’re dedicated to ensuring our staff’s safety by continuing to strengthen a culture that prioritizes workplace safety.
Categorie: Istituzioni

Coronavirus (COVID-19) Update: Daily Roundup October 7, 2020

Food and Drug Administration - Mer, 07/10/2020 - 23:32
The FDA issues letter to healthcare providers regarding SARS-CoV-2 testing, and a warning letter for failure to comply with regulatory reporting requirements.
Categorie: Istituzioni

FDA Issues Warning Letter to Battelle Memorial Institute, a Manufacturer of an Authorized Decontamination System Used on Respirators

Food and Drug Administration - Mer, 07/10/2020 - 19:44
FDA issued a warning letter to Battelle Memorial Institute for failure to comply with regulatory requirements for medical device reporting.
Categorie: Istituzioni

Coronavirus (COVID-19) Update: Daily Roundup October 6, 2020

Food and Drug Administration - Mer, 07/10/2020 - 01:28
The FDA launches new COVID-19 vaccine webpage and issues guidance with recommendations for vaccine sponsors.
Categorie: Istituzioni

Coronavirus (COVID-19) Update: Daily Roundup October 5, 2020

Food and Drug Administration - Lun, 05/10/2020 - 23:01
Coronavirus (COVID-19) Update: Daily Roundup for October 5, 2020
Categorie: Istituzioni

FDA, Mexican Counterparts Enhance Food Safety Partnership

Food and Drug Administration - Lun, 05/10/2020 - 20:20
Today, the FDA and its regulatory counterparts in Mexico enhanced a partnership to broaden and strengthen the scope of their existing partnership to include the safety of all human food regulated by the FDA.
Categorie: Istituzioni

Coronavirus (COVID-19) Update: Daily Roundup October 2, 2020

Food and Drug Administration - Ven, 02/10/2020 - 23:43
Coronavirus (COVID-19) Update: Daily Roundup
Categorie: Istituzioni

FDA Approves Drug Combination for Treating Mesothelioma

Food and Drug Administration - Ven, 02/10/2020 - 20:44
Today, the FDA approved Opdivo (nivolumab) in combination with Yervoy (ipilimumab) for the first-line treatment of adults with malignant pleural mesothelioma that cannot be removed by surgery.
Categorie: Istituzioni

Coronavirus (COVID-19) Update: Daily Roundup October 1, 2020

Food and Drug Administration - Gio, 01/10/2020 - 23:25
Coronavirus (COVID-19) Update: Daily Roundup
Categorie: Istituzioni