Istituzioni
FDA Publishes List of Essential Medicines, Medical Countermeasures, Critical Inputs Required by Executive Order
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
Coronavirus (COVID-19) Update
Categorie: Istituzioni
FDA Approves Lotion for Nonprescription Use to Treat Head Lice
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
Coronavirus (COVID-19) Update: Daily Roundup
Categorie: Istituzioni
Coronavirus (COVID-19) Update: Daily Roundup October 23, 2020
Coronavirus (COVID-19) Update: Daily Roundup
Categorie: Istituzioni
FDA Approves First Treatment for COVID-19
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
Coronavirus (COVID-19) Update: Daily Roundup
Categorie: Istituzioni
Coronavirus (COVID-19) Update: Daily Roundup October 19, 2020
Coronavirus (COVID-19) Update: Daily Roundup of FDA Actions, October 19, 2020
Categorie: Istituzioni
Coronavirus (COVID-19) Update: Daily Roundup October 15, 2020
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
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
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
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
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
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
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
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
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
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
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
FDA issued a warning letter to Battelle Memorial Institute for failure to comply with regulatory requirements for medical device reporting.
Categorie: Istituzioni
