Istituzioni

Coronavirus (COVID-19) Update: FDA Actively Working to Investigate, Address Potential Impacts of Omicron Variant; Urges Vaccination and Boosters

Food and Drug Administration - Ma, 30/11/2021 - 16:13
FDA is working with federal partners, international regulators and medical product companies to quickly address any potential impacts of the omicron variant.
Categorie: Istituzioni

FDA Approves New Imaging Drug to Help Identify Ovarian Cancer Lesions

Food and Drug Administration - Lu, 29/11/2021 - 16:52
The FDA today approved Cytalux, an imaging drug intended to assist surgeons in identifying ovarian cancer lesions. The drug is designed to improve the ability to locate additional ovarian cancerous tissue that is normally difficult to detect during surgery.
Categorie: Istituzioni

FDA Approves First Treatment for Common Type of Post-Transplant Infection that is Resistant to Other Drugs

Food and Drug Administration - Ma, 23/11/2021 - 22:36
The FDA approved the first drug for treating adults and pediatric patients with post-transplant cytomegalovirus infection/disease that does not respond (with or without genetic mutations that cause resistance) to available antiviral treatment for cytomegalovirus.
Categorie: Istituzioni

Coronavirus (COVID-19) Update: November 23, 2021

Food and Drug Administration - Ma, 23/11/2021 - 21:11
Coronavirus (COVID-19) Update: November 23, 2021
Categorie: Istituzioni

FDA Approves First Drug to Improve Growth in Children with Most Common Form of Dwarfism

Food and Drug Administration - Ve, 19/11/2021 - 18:34
The FDA approved a drug to improve growth in children five years of age and older with achondroplasia and open growth plates, meaning these children still have the potential to grow. Achondroplasia is the most common form of dwarfism.
Categorie: Istituzioni

FDA In Brief: FDA Issues Final Orders Reclassifying Certain Hepatitis C Diagnostic Tests from Class III to Class II

Food and Drug Administration - Ve, 19/11/2021 - 15:47
Today, the FDA issued two final orders, reclassifying certain HCV diagnostic tests from class III to II. These orders allow these HCV tests to use FDA’s 510(k) pathway rather than the PMA pathway.
Categorie: Istituzioni

Coronavirus (COVID-19) Update: FDA Expands Eligibility for COVID-19 Vaccine Boosters

Food and Drug Administration - Ve, 19/11/2021 - 14:41
The FDA amended the emergency use authorizations for both the Moderna and Pfizer-BioNTech COVID-19 vaccines authorizing use of a single booster dose for all individuals 18 years of age and older after completion of primary vaccination with any FDA-authorized or approved COVID-19 vaccine.
Categorie: Istituzioni

FDA In Brief: FDA Announces Investigation of E. coli O157:H7 Outbreak Linked to Spinach

Food and Drug Administration - Ma, 16/11/2021 - 21:37
The FDA, along with the CDC and our state and local partners, are working to investigate a multistate outbreak of E.coli O157:H7.
Categorie: Istituzioni

Coronavirus (COVID-19) Update: November 16, 2021

Food and Drug Administration - Ma, 16/11/2021 - 20:23
Coronavirus (COVID-19) Update: November 16, 2021
Categorie: Istituzioni

FDA Authorizes Marketing of Virtual Reality System for Chronic Pain Reduction

Food and Drug Administration - Ma, 16/11/2021 - 18:41
The FDA authorized marketing of EaseVRx, a prescription-use immersive virtual reality (VR) system that uses cognitive behavioral therapy and other behavioral methods to help with pain reduction in patients 18 years of age and older with diagnosed chronic lower back pain.
Categorie: Istituzioni

Coronavirus (COVID-19) Update: FDA Updates Test Policies to Help to Ensure Accuracy and Reliability of Tests and Increase Access to At-Home Tests

Food and Drug Administration - Lu, 15/11/2021 - 16:08
Today, the U.S. Food and Drug Administration is taking several important actions to support ongoing nationwide COVID-19 testing efforts. These actions are aimed at further increasing access to accurate and reliable COVID-19 tests.
Categorie: Istituzioni

FDA Approves Treatment for Rare Blood Disease

Food and Drug Administration - Ve, 12/11/2021 - 22:43
he FDA approved a new drug to treat adults with polycythemia vera, a blood disease that causes the overproduction of red blood cells. The drug is the first FDA-approved option patients can take regardless of previous therapies.
Categorie: Istituzioni

FDA Provides Update on Recall of Certain Philips Respironics Breathing Assistance Machines

Food and Drug Administration - Ve, 12/11/2021 - 21:49
Today, the FDA is providing an update related to the June 14, 2021, recall of certain Philips Respironics ventilators, continuous positive airway pressure (CPAP) and bilevel positive airway pressure (BiPAP) machines.
Categorie: Istituzioni

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

Food and Drug Administration - Ve, 12/11/2021 - 21:12
Coronavirus (COVID-19) Update: November 12, 2021
Categorie: Istituzioni

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

Food and Drug Administration - Ve, 05/11/2021 - 20:44
Coronavirus (COVID-19) Update: November 5, 2021
Categorie: Istituzioni

FDA In Brief: FDA Provides New Draft Guidance on Premarket Submissions for Device Software Functions

Food and Drug Administration - Me, 03/11/2021 - 15:19
The FDA is making available the draft guidance Content of Premarket Submissions for Device Software Functions intended to provide information regarding the recommended documentation to include in premarket submissions for the FDA to evaluate the safety and effectiveness of device software functions
Categorie: Istituzioni

Coronavirus (COVID-19) Update: November 2, 2021

Food and Drug Administration - Ma, 02/11/2021 - 21:58
Coronavirus (COVID-19) Update: November 2, 2021
Categorie: Istituzioni

Coronavirus (COVID-19) Update: October 29, 2021

Food and Drug Administration - Ve, 29/10/2021 - 21:04
Coronavirus (COVID-19) Update: October 29, 2021
Categorie: Istituzioni

FDA Authorizes Pfizer-BioNTech COVID-19 Vaccine for Emergency Use in Children 5 through 11 Years of Age

Food and Drug Administration - Ve, 29/10/2021 - 20:09
FDA authorized the emergency use of the Pfizer-BioNTech COVID-19 Vaccine for the prevention of COVID-19 to include children 5 through 11 years of age.
Categorie: Istituzioni

FDA, NIH, and 15 private organizations join forces to increase effective gene therapies for rare diseases

Food and Drug Administration - Me, 27/10/2021 - 21:05
FDA, NIH, 10 pharmaceutical companies and five non-profit organizations have partnered to accelerate development of gene therapies for the 30 million Americans who suffer from a rare disease.
Categorie: Istituzioni
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