Food and Drug Administration

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FDA Roundup: August 12, 2022

Ve, 12/08/2022 - 21:21
The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency.
Categorie: Istituzioni

FDA Infant Formula Update: August 10, 2022

Me, 10/08/2022 - 23:19
FDA exercises enforcement discretion to Reckitt Nutrition/Mead Johnson Nutrition to import Base Powder for PurAmino Hypoallergenic Infant Formula (amino acid-based infant formula with iron) infant formula products from Mexico following review of nutritional adequacy and safety information, including
Categorie: Istituzioni

Monkeypox Update: FDA Authorizes Emergency Use of JYNNEOS Vaccine to Increase Vaccine Supply

Ma, 09/08/2022 - 21:31
The FDA issued an emergency use authorization (EUA) for the JYNNEOS vaccine to increase vaccine supply by up to five-fold and to allow for individuals under 18 years of age determined to be at high risk of monkeypox infection to receive the vaccine.
Categorie: Istituzioni

FDA Roundup: August 9, 2022

Ma, 09/08/2022 - 18:54
The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency.
Categorie: Istituzioni

FDA Issues Warning Letters to Three Companies for Selling Unapproved New Drugs for Mole and Skin Tag Removal

Ma, 09/08/2022 - 16:25
Today, the FDA issued three warning letters to companies for introducing products for mole and skin tag removal into interstate commerce that are unapproved new drugs.
Categorie: Istituzioni

FDA Roundup: August 5, 2022

Ve, 05/08/2022 - 20:04
The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency.
Categorie: Istituzioni

FDA Infant Formula Update: August 5, 2022

Ve, 05/08/2022 - 17:39
FDA Infant Formula Update: August 5 Nestlé (The Netherlands)
Categorie: Istituzioni

FDA Approves First Targeted Therapy for HER2-Low Breast Cancer

Ve, 05/08/2022 - 17:25
FDA Approves First Targeted Therapy for HER2-Low Breast Cancer
Categorie: Istituzioni

FDA Continues Efforts to Support Innovation in Medical Device Sterilization

Me, 03/08/2022 - 17:38
The FDA provides updates on its work to promote innovative ways to sterilize medical devices while reducing adverse impacts on the environment and on the public health, but also developing solutions to avoid potential shortages of medical devices.
Categorie: Istituzioni

FDA Roundup: August 2, 2022

Ma, 02/08/2022 - 18:27
The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency.
Categorie: Istituzioni

FDA Roundup: July 29, 2022

Ve, 29/07/2022 - 22:15
The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency.
Categorie: Istituzioni

FDA Infant Formula Update: July 29, 2022

Ve, 29/07/2022 - 21:31
Today, the FDA is providing an update on additional steps it has taken that will lead to more infant formula available in the U.S.
Categorie: Istituzioni

FDA Provides Update on Agency Response to Monkeypox Outbreak

Ve, 29/07/2022 - 20:39
Today, the FDA is providing an update on its multipronged response to monkeypox in the United States, including its efforts in the areas of diagnostics, vaccines and therapeutics.
Categorie: Istituzioni

FDA Seeks to Improve Patient Communication on LASIK Benefits and Risks Through Issuance of Draft Guidance

Me, 27/07/2022 - 16:02
FDA issues draft guidance to help ensure that information is available to patients and health care professionals to clearly communicate the benefits and risks of LASIK devices.
Categorie: Istituzioni

FDA Roundup: July 26, 2022

Ma, 26/07/2022 - 21:09
The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency.
Categorie: Istituzioni

FDA Roundup: July 22, 2022

Ve, 22/07/2022 - 22:50
The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency.
Categorie: Istituzioni

FDA Details Optimized Approach for Regulatory Oversight Tools to Better Protect Public Health

Ve, 22/07/2022 - 15:40
FDA provides draft guidance on remote regulatory assessments for their use and, once finalized, how they will be consistently incorporated for all FDA-regulated products beyond the public health emergency.
Categorie: Istituzioni

FDA Conducting Evaluation of Key Agency Activities to Strengthen Operations

Ma, 19/07/2022 - 21:58
The FDA is conducting an evaluation of key agency activities to strengthen operations.
Categorie: Istituzioni

FDA Roundup: July 19, 2022

Ma, 19/07/2022 - 19:31
The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency.
Categorie: Istituzioni

FDA Roundup: July 15, 2022

Ve, 15/07/2022 - 22:22
The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency.
Categorie: Istituzioni