Food and Drug Administration

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FDA Issues Final Order and Guidance on Surgical Staplers and Staples for Internal Use

Gio, 07/10/2021 - 16:21
FDA issues final order reclassifying surgical staplers for internal use requiring them to undergo premarket review, final guidance for labeling requirements for patient risk communication and a letter to health care providers to increase their safe use.
Categorie: Istituzioni

FDA Announces Signing of Domestic Mutual Reliance Agreements with California, Florida, Utah and Wisconsin

Gio, 07/10/2021 - 15:46
The FDA announced that California, Florida, Utah and Wisconsin have entered into domestic mutual reliance agreements with the agency
Categorie: Istituzioni

FDA In Brief: FDA Warns Firms for Continuing to Market E-cigarette Products After Agency Denied Authorizations

Gio, 07/10/2021 - 14:57
FDA issued warning letters to 20 companies for continuing to unlawfully market e-cigarette products with Marketing Denial Orders.
Categorie: Istituzioni

FDA Revises Hospital and Health System Compounding Guidance to Help Preserve Patient Access to Compounded Drugs

Mer, 06/10/2021 - 16:18
FDA is revising its Hospital and Health System Compounding Guidance to Help Preserve Patient Access to Compounded Drugs
Categorie: Istituzioni

Coronavirus (COVID-19) Update: October 5, 2021

Mar, 05/10/2021 - 20:34
Coronavirus (COVID-19) Update: October 5, 2021
Categorie: Istituzioni

Coronavirus (COVID-19) Update: FDA Authorizes Additional OTC Home Test to Increase Access to Rapid Testing for Consumers

Lun, 04/10/2021 - 20:55
FDA issued an emergency use authorization (EUA) for the ACON Laboratories Flowflex COVID-19 Home Test, an over-the-counter (OTC) COVID-19 test, which adds to the growing list of tests that can be used at home without a prescription.
Categorie: Istituzioni

FDA Finalizes Two Foundational Rules for Companies Seeking to Market New Tobacco Products

Lun, 04/10/2021 - 15:02
Today, the U.S. Food and Drug Administration issued two final rules for the premarket review of new tobacco products.
Categorie: Istituzioni

Federal officials seize spices and food additive products held under insanitary conditions from a Florida warehouse

Ven, 01/10/2021 - 20:43
On behalf of the agency, U.S. Marshals Service conducted a mass seizure of FDA-regulated spices and food additive products held for sale under insanitary conditions that were exposed to widespread rodent infestation as well as other pests, such as live and dead insects.
Categorie: Istituzioni

Coronavirus (COVID-19) Update: October 1, 2021

Ven, 01/10/2021 - 20:16
Coronavirus (COVID-19) Update: October 1, 2021
Categorie: Istituzioni

FDA to Hold Advisory Committee Meetings to Discuss Emergency Use Authorization for Booster Doses and COVID-19 Vaccines for Younger Children

Ven, 01/10/2021 - 19:12
The FDA is announcing two upcoming meetings of its Vaccines and Related Biological Products Advisory Committee (VRBPAC) to discuss newly available data for the currently available COVID-19 vaccines.
Categorie: Istituzioni