Istituzioni

FDA In Brief: FDA Collaborates with Health Canada and UK’s MHRA to Foster Good Machine Learning Practice

Food and Drug Administration - Me, 27/10/2021 - 15:43
Today, FDA, Health Canada and the UK’s MHRA jointly issued the “Good Machine Learning Practice for Medical Device Development: Guiding Principles” to identify a set of ten guiding principles that are important to be included in the development of Good Machine Learning Practice (GMLP).
Categorie: Istituzioni

Coronavirus (COVID-19) Update: October 26, 2021

Food and Drug Administration - Ma, 26/10/2021 - 18:34
Coronavirus (COVID-19) Update: October 26, 2021
Categorie: Istituzioni

FDA In Brief: FDA Makes Progress on Efforts to Understand Presence of Asbestos in Cosmetic Products

Food and Drug Administration - Lu, 25/10/2021 - 16:32
The FY 2020 - 2021 sampling assignment tested talc-containing cosmetic products for the presence of asbestos, all samples tested negative and there were no positive findings
Categorie: Istituzioni

Coronavirus (COVID-19) Update: October 22, 2021

Food and Drug Administration - Ve, 22/10/2021 - 19:57
Coronavirus (COVID-19) Update: October 22, 2021
Categorie: Istituzioni

FDA In Brief: FDA Announces Investigation of Salmonella Outbreak Linked to Whole, Fresh Onions

Food and Drug Administration - Gi, 21/10/2021 - 00:13
The FDA, along with the CDC and our state and local partners, are working to investigate a multistate outbreak of Salmonella Oranienburg infections linked to linked to whole, fresh onions
Categorie: Istituzioni

Coronavirus (COVID-19) Update: FDA Takes Additional Actions on the Use of a Booster Dose for COVID-19 Vaccines

Food and Drug Administration - Me, 20/10/2021 - 21:43
The FDA took additional actions regarding booster doses of COVID-19 vaccines, including authorizing heterologous (or “mix and match”) booster doses in eligible individuals following completion of primary vaccination with a different available COVID-19 vaccine.
Categorie: Istituzioni

Federal Judge Enters Consent Decree with Utah-based Dietary Supplement Manufacturer

Food and Drug Administration - Me, 20/10/2021 - 19:18
A dietary supplement manufacturer has been ordered to stop selling products until they come into compliance under the Federal Food, Drug, and Cosmetic Act
Categorie: Istituzioni

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

Food and Drug Administration - Ma, 19/10/2021 - 19:05
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 - Ma, 19/10/2021 - 16:42
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 - Ma, 19/10/2021 - 13:54
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 - Lu, 18/10/2021 - 15:27
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 - Ve, 15/10/2021 - 21:35
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 - Gi, 14/10/2021 - 18:34
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 - Gi, 14/10/2021 - 18:25
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 - Me, 13/10/2021 - 12:05
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 - Ma, 12/10/2021 - 20:23
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 - Ma, 12/10/2021 - 20:22
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 - Ma, 12/10/2021 - 16:04
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 - Ve, 08/10/2021 - 23:11
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 - Ve, 08/10/2021 - 19:30
Coronavirus (COVID-19) Update
Categorie: Istituzioni
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