Istituzioni

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

Food and Drug Administration - Mar, 07/09/2021 - 22:06
Coronavirus (COVID-19) Update: September 7, 2021
Categorie: Istituzioni

FDA In Brief: FDA Reaches Milestone in Competitive Generic Therapy Drug Approvals

Food and Drug Administration - Gio, 02/09/2021 - 17:14
FDA In Brief: FDA Reaches Milestone in Competitive Generic Therapy Drug Approvals, Marking Success of Program that Encourages Development of Drugs with Inadequate Generic Competition
Categorie: Istituzioni

FDA In Brief: FDA to Hold Advisory Committee Meeting to Discuss Pfizer-BioNTech’s Application for COVID-19 Booster

Food and Drug Administration - Mer, 01/09/2021 - 22:54
FDA announced a virtual VRBPAC meeting to discuss the Pfizer-BioNTech supplemental application for a third (“booster”) dose of Comirnaty (COVID-19 Vaccine, mRNA).
Categorie: Istituzioni

Coronavirus (COVID-19) Update: August 31, 2021

Food and Drug Administration - Mar, 31/08/2021 - 21:11
Coronavirus (COVID-19) Update: August 31, 2021
Categorie: Istituzioni

Coronavirus (COVID-19) Update: August 27, 2021

Food and Drug Administration - Ven, 27/08/2021 - 21:18
Coronavirus (COVID-19) Update: August 27, 2021
Categorie: Istituzioni

FDA Approves First-of-Its-Kind Stroke Rehabilitation System

Food and Drug Administration - Ven, 27/08/2021 - 16:54
The FDA approved the MicroTransponder Vivistim Paired VNS System, a rehabilitation system intended to treat moderate to severe upper extremity motor deficits associated with chronic ischemic stroke using vagus nerve stimulation.
Categorie: Istituzioni

FDA Denies Marketing Applications for About 55,000 Flavored E-Cigarette Products for Failing to Provide Evidence They Appropriately Protect Public Health

Food and Drug Administration - Gio, 26/08/2021 - 23:27
FDA issued marketing denial orders for flavored e-cigarettes after determining applications lacked sufficient evidence.
Categorie: Istituzioni

FDA Releases PFAS Testing Results from First Survey of Nationally Distributed Processed Foods

Food and Drug Administration - Gio, 26/08/2021 - 16:24
FDA Releases PFAS Testing Results from First Survey of Nationally Distributed Processed Foods; Nearly all foods tested had no detectable levels of PFAS; no evidence that levels found in samples indicate need to avoid particular foods
Categorie: Istituzioni

Coronavirus (COVID-19) Update: August 24, 2021

Food and Drug Administration - Mar, 24/08/2021 - 21:39
Coronavirus (COVID-19) Update: August 24, 2021
Categorie: Istituzioni

FDA and Mexican Counterparts Report Progress and Next Steps for Food Safety Partnership

Food and Drug Administration - Lun, 23/08/2021 - 17:47
FDA and its regulatory counterparts in Mexico held the first Food Safety Partnership Annual Meeting.
Categorie: Istituzioni

FDA Approves First COVID-19 Vaccine

Food and Drug Administration - Lun, 23/08/2021 - 15:33
FDA approved the first COVID-19 vaccine, which has been known as the Pfizer-BioNTech COVID-19 Vaccine, and is now marketed as Comirnaty (koe-mir’-na-tee), for the prevention of COVID-19 disease in individuals 16 years of age and older.
Categorie: Istituzioni

Coronavirus (COVID-19) Update: August 20, 2021

Food and Drug Administration - Ven, 20/08/2021 - 19:46
Coronavirus (COVID-19) Update: August 20, 2021
Categorie: Istituzioni

Joint Statement from HHS Public Health and Medical Experts on COVID-19 Booster Shots

Food and Drug Administration - Mer, 18/08/2021 - 19:01
Public health and medical experts from the U.S. Department of Health and Human Services released a statement on the Administration’s plan for COVID-19 booster shots for the American people.
Categorie: Istituzioni

FDA In Brief: FDA Issues a Corporate-Wide Warning Letter to Company Associated with Contaminated Pet Food, Hundreds of Adverse Events

Food and Drug Administration - Mar, 17/08/2021 - 20:40
The FDA has issued a corporate-wide warning letter to Midwestern Pet Foods, Inc. after inspections of its manufacturing sites revealed apparent violations of the Federal Food, Drug, and Cosmetic Act shared across multiple sites
Categorie: Istituzioni

Coronavirus (COVID-19) Update: August 13, 2021

Food and Drug Administration - Ven, 13/08/2021 - 22:03
Coronavirus (COVID-19) Update
Categorie: Istituzioni

Coronavirus (COVID-19) Update: FDA Authorizes Additional Vaccine Dose for Certain Immunocompromised Individuals

Food and Drug Administration - Ven, 13/08/2021 - 05:08
The FDA amended the EUAs for the Pfizer-BioNTech and Moderna COVID-19 Vaccines to allow an additional dose in certain immunocompromised individuals, specifically solid organ transplant recipients or those with conditions that are considered to have an equivalent level of immunocompromise.
Categorie: Istituzioni

FDA Grants First of its Kind Indication for Chronic Sleep Disorder Treatment

Food and Drug Administration - Gio, 12/08/2021 - 22:23
Today, the FDA approved a novel indication for drug Xywav
Categorie: Istituzioni

Coronavirus (COVID-19) Update: August 6, 2021

Food and Drug Administration - Ven, 06/08/2021 - 23:10
Coronavirus (COVID-19) Update: August 6, 2021
Categorie: Istituzioni

FDA Approves New Treatment for Pompe Disease

Food and Drug Administration - Ven, 06/08/2021 - 16:35
Today the FDA approved Nexviazyme (avalglucosidase alfa-ngpt) for intravenous infusion to treat patients 1 year of age and older with late-onset Pompe disease.
Categorie: Istituzioni

FDA In Brief: FDA Reminds Industry of Specific Regulations for the Use of Fluorinated Polyethylene in Food Contact Containers

Food and Drug Administration - Gio, 05/08/2021 - 19:35
FDA Reminds Industry of Specific Regulations for the Use of Fluorinated Polyethylene in Food Contact Containers
Categorie: Istituzioni