Istituzioni

FDA Approves New Opioid for Intravenous Use in Hospitals, Other Controlled Clinical Settings

FDA has approved Olinvyk (oliceridine), an opioid agonist for the management of moderate to severe acute pain in adults, where the pain is severe enough to require an IV opioid and for whom alternatives are inadequate.
Categorie: Istituzioni

Coronavirus (COVID-19) Update: Daily Roundup August 7, 2020

Food and Drug Administration - Ve, 07/08/2020 - 22:30
Coronavirus (COVID-19) Update: Daily Roundup
Categorie: Istituzioni

FDA Approves First Liquid Biopsy Next-Generation Sequencing Companion Diagnostic Test

Food and Drug Administration - Ve, 07/08/2020 - 21:09
FDA approves first liquid biopsy NGS companion diagnostic. This marks the first approval to combine these two technologies — NGS and liquid biopsy — in one diagnostic test in order to guide treatment decisions.
Categorie: Istituzioni

FDA Approves Oral Treatment for Spinal Muscular Atrophy

Food and Drug Administration - Ve, 07/08/2020 - 20:38
The FDA has approved Evrysdi (risdiplam) to treat patients two months and older with spinal muscular atrophy, a rare and often fatal genetic disease affecting muscle strength and movement. This is the second drug and the first oral drug approved to treat this disease.
Categorie: Istituzioni

Coronavirus (COVID-19) Update: Daily Roundup August 6, 2020

Food and Drug Administration - Gi, 06/08/2020 - 23:48
Coronavirus (COVID-19) Update: Daily Roundup
Categorie: Istituzioni

Coronavirus (COVID-19) Update: Daily Roundup August 5, 2020

Food and Drug Administration - Me, 05/08/2020 - 23:20
Coronavirus (COVID-19) Update: Daily Roundup
Categorie: Istituzioni

Coronavirus (COVID-19) Update: Daily Roundup August 4, 2020

Food and Drug Administration - Me, 05/08/2020 - 00:42
Coronavirus (COVID-19) Update: Daily Roundup
Categorie: Istituzioni

La FDA les recomienda a los consumidores que eviten las cebollas rojas de un proveedor en California; la investigación continúa para encontrar la fuente

Food and Drug Administration - Ma, 04/08/2020 - 00:12
La FDA les recomienda a los consumidores que eviten las cebollas rojas de un proveedor en California; la investigación continúa para encontrar la fuente.
Categorie: Istituzioni

Coronavirus (COVID-19) Update: Daily Roundup August 3, 2020

Food and Drug Administration - Lu, 03/08/2020 - 23:02
Coronavirus (COVID-19) Update: Daily Roundup
Categorie: Istituzioni

FDA Approves New Indication for Drug Containing an Active Ingredient Derived from Cannabis to Treat Seizures in Rare Genetic Disease

Food and Drug Administration - Sa, 01/08/2020 - 02:54
The FDA has approved a new indication for drug to treat seizures associated with tuberous sclerosis complex.
Categorie: Istituzioni

Coronavirus (COVID-19) Update: FDA Authorizes First Tests that Estimate a Patient’s Antibodies from Past SARS-CoV-2 Infection

Food and Drug Administration - Sa, 01/08/2020 - 01:16
Today, the U.S. Food and Drug Administration authorized the first two COVID-19 serology tests that display an estimated quantity of antibodies present in the individual’s blood
Categorie: Istituzioni

Coronavirus (COVID-19) Update: Daily Roundup July 31, 2020

Food and Drug Administration - Ve, 31/07/2020 - 22:56
FDA's actions on July 31, 2020 in its ongoing response to the COVID-19 pandemic.
Categorie: Istituzioni

FDA Announces Voluntary Agreement with Manufacturers to Phase Out Certain Short-Chain PFAS Used in Food Packaging

Food and Drug Administration - Ve, 31/07/2020 - 16:28
The FDA is announcing that the manufacturers of certain per- and polyfluoroalkyl substances (PFAS) used for grease-proofing in paper and paperboard for food packaging have voluntarily agreed to phase-out their sales of these substances for use as food contact substances in the U.S.
Categorie: Istituzioni

Coronavirus (COVID-19) Update: Daily Roundup July 30, 2020

Food and Drug Administration - Gi, 30/07/2020 - 23:33
FDA's actions on July 30, 2020in the ongoing response to the COVID-19 pandemic
Categorie: Istituzioni

FDA Announces New Protocol for the Development and Registration of Treatments for Preharvest Agricultural Water

Food and Drug Administration - Gi, 30/07/2020 - 21:25
The FDA announced a new protocol for the development and registration of antimicrobial treatments for preharvest agricultural water, such as the water used in farm irrigation systems.
Categorie: Istituzioni

FDA Warns Companies Illegally Selling Hangover Remedies

Food and Drug Administration - Gi, 30/07/2020 - 00:53
FDA has issued warning letters to seven companies for illegally selling unapproved products labeled as dietary supplements that claim to cure, treat, mitigate or prevent hangovers.
Categorie: Istituzioni

Coronavirus (COVID-19) Update: Daily Roundup July 29, 2020

Food and Drug Administration - Me, 29/07/2020 - 23:54
FDA actions on July 29, 2020 on updated molecular diagnostic templates for labs and industry preparing EUA requests, templates for commercial developers submitting EUA requests for at-home diagnostic tests, and more in its ongoing response to the COVID-19 pandemic.

Categorie: Istituzioni

Coronavirus (COVID-19) Update: FDA Posts New Template for At-Home and Over-the-Counter Diagnostic Tests for Use in Non-Lab Settings, Such as Homes, Offices or Schools

Food and Drug Administration - Me, 29/07/2020 - 18:36
The FDA has posted a new template for commercial developers to submit emergency use authorization (EUA) requests for COVID-19 diagnostic tests that can be performed entirely at home or in other everyday settings and that could be available without a prescription.
Categorie: Istituzioni

Coronavirus (COVID-19) Update: Daily Roundup July 28, 2020

Food and Drug Administration - Ma, 28/07/2020 - 22:44
Coronavirus (COVID-19) Update: Daily Roundup
Categorie: Istituzioni

Coronavirus (COVID-19) Update: Daily Roundup July 27, 2020

Food and Drug Administration - Lu, 27/07/2020 - 23:48
Coronavirus (COVID-19) Update: Daily Roundup
Categorie: Istituzioni
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