Istituzioni

Coronavirus (COVID-19) Update: December 21, 2021

Food and Drug Administration - Ma, 21/12/2021 - 23:06
Coronavirus (COVID-19) Update: December 21, 2021
Categorie: Istituzioni

FDA In Brief: FDA Announces Outbreak Investigation of Listeria monocytogenes Found in Fresh Express Packaged Salad

Food and Drug Administration - Ma, 21/12/2021 - 22:32
The FDA, along with the CDC and our state and local partners, are working to investigate a multistate outbreak of Listeria monocytogenes infections.
Categorie: Istituzioni

FDA Conditionally Approves First Oral Tablet to Treat Chemotherapy-Induced Diarrhea in Dogs

Food and Drug Administration - Ma, 21/12/2021 - 19:36
FDA conditionally approved Canalevia-CA1 (crofelemer delayed-release tablets) for the treatment of chemotherapy-induced diarrhea in dogs.
Categorie: Istituzioni

FDA Grants Marketing Authorization for Inferior Vena Cava Filter Removal Device

Food and Drug Administration - Ma, 21/12/2021 - 17:20
FDA has authorized marketing of the first laser-based device for removal of Inferior Vena Cava (IVC) filters. An IVC filter is a small cage-like device inserted into the largest vein in the body to capture blood clots and prevent them from traveling to the lungs.
Categorie: Istituzioni

FDA Approves First Injectable Treatment for HIV Pre-Exposure Prevention

Food and Drug Administration - Lu, 20/12/2021 - 21:31
Today, the FDA approved Apretude (cabotegravir extended-release injectable suspension) for use in at-risk adults and adolescents weighing at least 35 kilograms (77 pounds) for pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV.
Categorie: Istituzioni

FDA Approves New Treatment for Myasthenia Gravis

Food and Drug Administration - Ve, 17/12/2021 - 22:33
Today, the FDA approved Vyvgart for the treatment of generalized myasthenia gravis in certain adults
Categorie: Istituzioni

Coronavirus (COVID-19) Update: December 17, 2021

Food and Drug Administration - Ve, 17/12/2021 - 21:21
Coronavirus (COVID-19) Update: December 17, 2021
Categorie: Istituzioni

FDA Approves First Drug to Prevent Graft Versus Host Disease

Food and Drug Administration - Me, 15/12/2021 - 17:43
The FDA approved the first drug for the prevention of acute graft versus host disease, a condition that occurs when donor bone marrow or stem cells attack the graft recipient, in combination with certain immunosuppressants.
Categorie: Istituzioni

Coronavirus (COVID-19) Update: December 14, 2021

Food and Drug Administration - Ma, 14/12/2021 - 22:31
Coronavirus (COVID-19) Update: December 14, 2021
Categorie: Istituzioni

Coronavirus (COVID-19) Update: December 10, 2021

Food and Drug Administration - Ve, 10/12/2021 - 19:45
Coronavirus (COVID-19) Update: December 10, 2021
Categorie: Istituzioni

FDA In Brief: FDA Publishes Discussion Paper and Seeks Public Input on 3D Printing of Medical Devices at the Point of Care

Food and Drug Administration - Ve, 10/12/2021 - 17:17
Today, the FDA published a discussion paper regarding 3D printing medical devices at the point of care (PoC), such as hospitals and doctor’s offices.
Categorie: Istituzioni

Coronavirus (COVID-19) Update: FDA Expands Eligibility for Pfizer-BioNTech COVID-19 Booster Dose to 16- and 17-Year-Olds

Food and Drug Administration - Gi, 09/12/2021 - 17:15
The FDA amended the emergency use authorizations for the Pfizer-BioNTech COVID-19 Vaccine, authorizing the use of a single booster dose for administration to individuals 16 and 17 years of age at least six months after completion of primary vaccination with the Pfizer-BioNTech COVID-19 Vaccine.
Categorie: Istituzioni

FDA Issues Improvement Plan Focused on Modernizing Foodborne Illness Outbreak Responses

Food and Drug Administration - Gi, 09/12/2021 - 15:58
FDA Issues Improvement Plan Focused on Modernizing Foodborne Illness Outbreak Responses
Categorie: Istituzioni

Coronavirus (COVID-19) Update: FDA Authorizes New Long-Acting Monoclonal Antibodies for Pre-exposure Prevention of COVID-19 in Certain Individuals

Food and Drug Administration - Me, 08/12/2021 - 21:11
The FDA authorized new long-acting monoclonal antibodies for the pre-exposure prevention of COVID-19 in certain adults and pediatric individuals.
Categorie: Istituzioni

Coronavirus (COVID-19) Update: December 7, 2021

Food and Drug Administration - Ma, 07/12/2021 - 21:36
Coronavirus (COVID-19) Update: December 7, 2021
Categorie: Istituzioni

FDA In Brief: FDA Takes New Steps Aimed at Advancing Development of Individualized Medicines to Treat Genetic Diseases

Food and Drug Administration - Ma, 07/12/2021 - 20:31
Today, the FDA issued guidances focused on the development of treatments to target genetic diseases, based on an individual patient’s genes. These draft guidances, once finalized, are aimed at helping treatments reach patients in a timely manner.
Categorie: Istituzioni

FDA Expands Authorization of Two Monoclonal Antibodies for Treatment and Post-Exposure Prevention of COVID-19 to Younger Pediatric Patients, Including Newborns

Food and Drug Administration - Ve, 03/12/2021 - 20:23
FDA revised the EUA of bamlanivimab and etesevimab, administered together, to treat mild to moderate COVID-19 in all younger pediatric patients, including newborns. The drug combination is also now authorized for post-exposure prevention of COVID-19 in all pediatric patients, including newborns.
Categorie: Istituzioni

FDA Proposes Changes to Food Safety Modernization Act Rule to Enhance Safety of Agricultural Water Used on Produce

Food and Drug Administration - Gi, 02/12/2021 - 17:34
The FDA issued a proposed rule that aims to enhance the safety of produce and if finalized would require certain farms to evaluate potential contamination risks for the water used on crops before harvest and take additional mitigation measures to help protect public health.
Categorie: Istituzioni

Coronavirus (COVID-19) Update: November 30, 2021

Food and Drug Administration - Ma, 30/11/2021 - 21:39
Coronavirus (COVID-19) Update: November 30, 2021
Categorie: Istituzioni

Coronavirus (COVID-19) Update: FDA Actively Working to Investigate, Address Potential Impacts of Omicron Variant; Urges Vaccination and Boosters

Food and Drug Administration - Ma, 30/11/2021 - 16:13
FDA is working with federal partners, international regulators and medical product companies to quickly address any potential impacts of the omicron variant.
Categorie: Istituzioni
Condividi contenuti