Istituzioni

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

Food and Drug Administration - Mar, 19/10/2021 - 20:05
Coronavirus (COVID-19) Update: October 19, 2021
Categorie: Istituzioni

FDA Permits Marketing of New Oral Tobacco Products through Premarket Tobacco Product Application Pathway

Food and Drug Administration - Mar, 19/10/2021 - 17:42
FDA authorized the marketing of four new Verve oral tobacco products manufactured by U.S. Smokeless Tobacco Company LLC.
Categorie: Istituzioni

FDA Issues Landmark Proposal to Improve Access to Hearing Aid Technology for Millions of Americans

Food and Drug Administration - Mar, 19/10/2021 - 14:54
FDA issued a proposed rule to establish a new category of over-the-counter hearing aids. When finalized, the rule would allow hearing aids that fall within this category to be sold directly to consumers in stores or online without a medical exam or a fitting by an audiologist.
Categorie: Istituzioni

FDA Approves Cyltezo, the First Interchangeable Biosimilar to Humira

Food and Drug Administration - Lun, 18/10/2021 - 16:27
The U.S. Food and Drug Administration today approved the first interchangeable biosimilar product to treat certain inflammatory diseases. Cyltezo (adalimumab-adbm) is now approved as interchangeable with (and may be substituted for) its reference product Humira (adalimumab).
Categorie: Istituzioni

Coronavirus (COVID-19) Update: 10/15/21

Food and Drug Administration - Ven, 15/10/2021 - 22:35
Coronavirus (COVID-19) Update
Categorie: Istituzioni

FDA to Hold Advisory Committee Meeting to Discuss Merck and Ridgeback’s EUA Application for COVID-19 Oral Treatment

Food and Drug Administration - Gio, 14/10/2021 - 19:34
The FDA is announcing an upcoming meeting of its Antimicrobial Drugs Advisory Committee (AMDAC) to discuss Merck and Ridgeback’s Application for the Emergency Use of a COVID-19 Oral Treatment
Categorie: Istituzioni

FDA Awards 11 Grants to Clinical Trials to Develop New Medical Products for Rare Disease Treatments

Food and Drug Administration - Gio, 14/10/2021 - 19:25
Today, the U.S. Food and Drug Administration announced it has awarded 11 new clinical trial research grants, equaling more than $25 million of funding over the next four years.
Categorie: Istituzioni

To Improve Nutrition and Reduce the Burden of Disease, FDA Issues Food Industry Guidance for Voluntarily Reducing Sodium in Processed and Packaged Foods

Food and Drug Administration - Mer, 13/10/2021 - 13:05
FDA Issues Final Guidance to Food Industry for Voluntarily Reducing Sodium in Processed and Packaged Foods
Categorie: Istituzioni

Coronavirus (COVID-19) Update: October 12, 2021

Food and Drug Administration - Mar, 12/10/2021 - 21:23
Coronavirus (COVID-19) Update: October 12, 2021
Categorie: Istituzioni

FDA Permits Marketing of E-Cigarette Products, Marking First Authorization of Its Kind by the Agency

Food and Drug Administration - Mar, 12/10/2021 - 21:22
FDA authorized the marketing of three new tobacco products, marking the first set of electronic nicotine delivery system (ENDS) products ever to be authorized by the agency through the Premarket Tobacco Product Application (PMTA) pathway.
Categorie: Istituzioni

FDA In Brief: FDA Withdrawing Temporary Guidances for Alcohol-Based Hand Sanitizers

Food and Drug Administration - Mar, 12/10/2021 - 17:04
The FDA is withdrawing the temporary policies outlined in the guidances for the preparation of certain alcohol-based hand sanitizer products and alcohol for use in hand sanitizers
Categorie: Istituzioni

FDA Approves Innovative Treatment for Pediatric Patients with Congenital Athymia

Food and Drug Administration - Sab, 09/10/2021 - 00:11
FDA approves Rethymic for immune reconstitution in pediatric patients with congenital athymia which is the first thymus tissue product approved in the U.S.
Categorie: Istituzioni

Coronavirus (COVID-19) Update: October 8, 2021

Food and Drug Administration - Ven, 08/10/2021 - 20:30
Coronavirus (COVID-19) Update
Categorie: Istituzioni

FDA In Brief: FDA Warns Public and Health Care Professionals Not to Use Needle-free Devices for Injection of Dermal Fillers

Food and Drug Administration - Ven, 08/10/2021 - 20:10
FDA is warning the public and health care professionals not to use needle-free devices commonly referred to as dermal fillers or fillers.
Categorie: Istituzioni

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

Food and Drug Administration - Gio, 07/10/2021 - 17:21
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

Food and Drug Administration - Gio, 07/10/2021 - 16:46
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

Food and Drug Administration - Gio, 07/10/2021 - 15:57
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

Food and Drug Administration - Mer, 06/10/2021 - 17:18
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

Food and Drug Administration - Mar, 05/10/2021 - 21:34
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

Food and Drug Administration - Lun, 04/10/2021 - 21:55
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