Food and Drug Administration

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FDA Roundup: January 25, 2022

Ma, 25/01/2022 - 22:12
The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency.
Categorie: Istituzioni

Coronavirus (COVID-19) Update: FDA Limits Use of Certain Monoclonal Antibodies to Treat COVID-19 Due to the Omicron Variant

Lu, 24/01/2022 - 22:37
The FDA revised the authorizations for two monoclonal antibody treatments to limit their use to only when the patient is likely to have been infected with or exposed to a variant that is susceptible of these treatments.
Categorie: Istituzioni

FDA Takes Actions to Expand Use of Treatment for Outpatients with Mild-to-Moderate COVID-19

Sa, 22/01/2022 - 00:16
The FDA took two actions to expand the use of the antiviral drug Veklury (remdesivir) to certain non-hospitalized adults and pediatric patients for the treatment of mild-to-moderate COVID-19 disease in places such as skilled nursing facilities, home healthcare settings and outpatient facilities.
Categorie: Istituzioni

FDA Roundup: January 21, 2022

Ve, 21/01/2022 - 20:36
The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency.
Categorie: Istituzioni

FDA Roundup: January 18, 2022

Ma, 18/01/2022 - 22:03
he U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency.
Categorie: Istituzioni

FDA Releases CDRH Health of Women Strategic Plan to Better Inform Medical Device Research and Regulation for All Women

Ma, 18/01/2022 - 16:02
The FDA’s Center for Devices and Radiological Health (CDRH) is sharing its Health of Women Program Strategic Plan to further the FDA’s mission by protecting and promoting the health of all women.
Categorie: Istituzioni

FDA Roundup: January 14, 2022

Ve, 14/01/2022 - 20:09
The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency.
Categorie: Istituzioni

FDA Releases Federal Interagency Working Group Scientific Opinions on Testing Methods for Asbestos in Talc-Containing Cosmetic Products

Gi, 13/01/2022 - 17:29
Interagency Working Group on Asbestos in Consumer Products (IWGACP) White Paper offers opinions on testing methods of talc-containing cosmetics products to assess the presence of asbestos
Categorie: Istituzioni

FDA Approves Novel Treatment to Control Pain in Cats with Osteoarthritis, First Monoclonal Antibody Drug for Use in Any Animal Species

Gi, 13/01/2022 - 16:22
FDA Approves Novel Treatment to Control Pain in Cats with Osteoarthritis, First Monoclonal Antibody Drug for Use in Any Animal Species
Categorie: Istituzioni

FDA Roundup: January 11, 2022

Ma, 11/01/2022 - 23:02
The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency.
Categorie: Istituzioni

FDA Roundup: January 7, 2022

Ve, 07/01/2022 - 22:09
The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency.
Categorie: Istituzioni

Coronavirus (COVID-19) Update: FDA Shortens Interval for Booster Dose of Moderna COVID-19 Vaccine to Five Months

Ve, 07/01/2022 - 14:59
The FDA amended the emergency use authorization (EUA) for the Moderna COVID-19 Vaccine to shorten the time between the completion of a primary series of the vaccine and a booster dose to at least five months for individuals 18 years of age and older.
Categorie: Istituzioni

FDA Roundup: January 4, 2022

Me, 05/01/2022 - 00:36
The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency.
Categorie: Istituzioni

Coronavirus (COVID-19) Update: FDA Takes Multiple Actions to Expand Use of Pfizer-BioNTech COVID-19 Vaccine

Lu, 03/01/2022 - 15:31
The FDA amended the emergency use authorization for the Pfizer-BioNTech COVID-19 Vaccine to take several actions that will expand the use of the vaccine in certain populations.
Categorie: Istituzioni

Coronavirus (COVID-19) Update: December 28, 2021

Ma, 28/12/2021 - 21:26
Coronavirus (COVID-19) Update: December 28, 2021
Categorie: Istituzioni

Coronavirus (COVID-19) Update: December 23, 2021

Gi, 23/12/2021 - 18:08
Coronavirus (COVID-19) Update: December 23, 2021
Categorie: Istituzioni

Coronavirus (COVID-19) Update: FDA Authorizes Additional Oral Antiviral for Treatment of COVID-19 in Certain Adults

Gi, 23/12/2021 - 15:19
The FDA issued an emergency use authorization for Merck’s molnupiravir for the treatment of mild-to-moderate COVID-19 in certain adults.
Categorie: Istituzioni

FDA Authorizes Marketing of Tobacco Products that Help Reduce Exposure to and Consumption of Nicotine for Smokers Who Use Them

Gi, 23/12/2021 - 15:04
The FDA authorized the marketing of 22nd Century Group Inc.’s “VLN King” and “VLN Menthol King” combusted, filtered cigarettes as modified risk tobacco products, which help reduce exposure to and consumption of nicotine for smokers who use them.
Categorie: Istituzioni

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

Gi, 23/12/2021 - 01:38
The FDA, along with the CDC and our state and local partners, is investigating a multistate outbreak of Listeria monocytogenes infections potentially linked to Dole packaged salad.
Categorie: Istituzioni

Coronavirus (COVID-19) Update: FDA Authorizes First Oral Antiviral for Treatment of COVID-19

Me, 22/12/2021 - 18:08
Today, the FDA issued an emergency use authorization for the first oral antiviral for treatment of COVID-19 in adults and pediatric patients (12 years of age and older weighing at least 40 kilograms or about 88 pounds).
Categorie: Istituzioni