Food and Drug Administration

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FDA Efforts to Result in Millions of Additional Bottles of Infant Formula to Further Increase U.S. Supply

Ve, 27/05/2022 - 19:51
The FDA is providing an update on additional steps it has taken that will lead to more infant formula on U.S. store shelves in the coming weeks and months.
Categorie: Istituzioni

FDA Flexibilities, Collaboration to Yield Millions of Bottles of Specialized Medical Infant Formula in Coming Months to Increase U.S. Supply

Gi, 26/05/2022 - 22:06
The FDA is providing an update on steps it has taken that will lead to millions of bottles of specialized medical infant formula to help address immediate needs for infants with certain allergies or critical health conditions.
Categorie: Istituzioni

FDA Flexibilities to Yield Millions of Cans of Additional Infant Formula in Coming Months to Increase Supply Available to U.S. Consumers

Ma, 24/05/2022 - 23:02
FDA is providing an update on steps it has taken that will lead to millions of cans of additional infant and specialty formula being available to U.S. consumers.
Categorie: Istituzioni

FDA Roundup: May 24, 2022

Ma, 24/05/2022 - 21:46
The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency.
Categorie: Istituzioni

FDA Approves First Treatment for Eosinophilic Esophagitis, a Chronic Immune Disorder

Ve, 20/05/2022 - 21:10
The FDA approved the first treatment for eosinophilic esophagitis, a chronic immune disorder, in adults and pediatric patients (12 years and older weighing at least 40 kilograms, which is about 88 pounds).
Categorie: Istituzioni

FDA Roundup: May 20, 2022

Ve, 20/05/2022 - 19:56
The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency.
Categorie: Istituzioni

FDA Urges Drug Manufacturers to Develop Risk Management Plans to Promote a Stronger, Resilient Drug Supply Chain

Gi, 19/05/2022 - 20:55
FDA is issuing a draft guidance, Risk Management Plans to Mitigate the Potential for Drug Shortages, intended to help with the development, maintenance and implementation of risk management plans.
Categorie: Istituzioni

New FDA Draft Guidance Aims to Increase Safety Information About Dietary Supplement Marketplace

Gi, 19/05/2022 - 16:43
The FDA announced the availability of a draft guidance aimed at increasing the amount of safety information the agency has about the dietary supplement marketplace by providing the industry an opportunity to submit late new dietary ingredient (NDI) notifications.
Categorie: Istituzioni

FDA Roundup: May 17, 2022

Ma, 17/05/2022 - 21:01
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 Expands Eligibility for Pfizer-BioNTech COVID-19 Vaccine Booster Dose to Children 5 through 11 Years

Ma, 17/05/2022 - 16:10
The FDA amended the emergency use authorization (EUA) for the Pfizer-BioNTech COVID-19 Vaccine, authorizing the use of a single booster dose for administration to individuals 5 through 11 years of age at least five months after completion of a primary series with the Pfizer-BioNTech COVID-19 Vaccine
Categorie: Istituzioni

FDA Encourages Importation of Safe Infant Formula and Other Flexibilities to Further Increase Availability

Ma, 17/05/2022 - 00:30
FDA announced guidance outlining increased flexibilities on importation of certain infant formula products to further increase the availability across the country while protecting the health of infants.
Categorie: Istituzioni

FDA Provides New Updates on Activities to Mitigate Infant Formula Supply Challenges, Abbott Nutrition Agrees to Take Corrective Actions at Facility to Produce Safe Infant Formula

Lu, 16/05/2022 - 23:47
Under the proposed consent decree, Abbott has agreed to take corrective actions following an FDA inspection of its Sturgis, Michigan, facility.
Categorie: Istituzioni

Coronavirus (COVID-19) Update: FDA Authorizes First COVID-19 Test Available without a Prescription That Also Detects Flu and RSV

Lu, 16/05/2022 - 20:57
Today, FDA authorized the Labcorp Seasonal Respiratory Virus RT-PCR DTC Test, the first direct-to-consumer (non-prescription) multi-analyte COVID-19 test authorized by FDA.
Categorie: Istituzioni

FDA Roundup: May 13, 2022

Ve, 13/05/2022 - 22:58
The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency.
Categorie: Istituzioni

FDA Approves Novel, Dual-Targeted Treatment for Type 2 Diabetes

Ve, 13/05/2022 - 21:01
The FDA approved a new treatment to improve blood sugar control in adults with type 2 diabetes, as an addition to diet and exercise.
Categorie: Istituzioni

FDA Roundup: May 10, 2022

Ma, 10/05/2022 - 22:48
The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency.
Categorie: Istituzioni

FDA Takes Important Steps to Improve Supply of Infant and Specialty Formula Products

Ma, 10/05/2022 - 22:39
The FDA is providing an update on its work to increase the availability of infant and specialty formula products.
Categorie: Istituzioni

FDA Roundup: May 6, 2022

Ve, 06/05/2022 - 22:26
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 Janssen COVID-19 Vaccine to Certain Individuals

Gi, 05/05/2022 - 22:50
The FDA has limited the authorized use of the Janssen COVID-19 Vaccine to individuals 18 older for whom other available COVID-19 vaccines are not accessible or clinically appropriate, and to individuals 18 and older who elect to receive it because they would otherwise not receive a COVID-19 vaccine.
Categorie: Istituzioni

FDA Permits Marketing for New Test to Improve Diagnosis of Alzheimer’s Disease

Me, 04/05/2022 - 20:36
FDA today permitted marketing for the first in vitro diagnostic test for early detection of amyloid plaques associated with Alzheimer’s disease.
Categorie: Istituzioni