Istituzioni

Coronavirus (COVID-19) Update: June 11, 2021

Food and Drug Administration - Ve, 11/06/2021 - 22:08
Coronavirus (COVID-19) Update: June 11, 2021
Categorie: Istituzioni

FDA Takes Steps to Increase Availability of COVID-19 Vaccine

Food and Drug Administration - Ve, 11/06/2021 - 17:19
FDA authorized two batches of Janssen’s COVID-19 vaccine drug substance manufactured at the Emergent BioSolutions facility in Baltimore
Categorie: Istituzioni

FDA In Brief: FDA Provides Guidance on Measuring Patient-Reported Outcomes in Cancer Clinical Trials

Food and Drug Administration - Me, 09/06/2021 - 17:21
The FDA issued draft guidance to address which patient-reported outcomes concepts to measure in cancer clinical trials.
Categorie: Istituzioni

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

Food and Drug Administration - Ma, 08/06/2021 - 22:17
Coronavirus (COVID-19) Update: June 8, 2021
Categorie: Istituzioni

FDA Grants Accelerated Approval for Alzheimer’s Drug

Food and Drug Administration - Lu, 07/06/2021 - 17:25
The FDA approved a drug for the treatment of Alzheimer’s under the accelerated approval pathway, which can be used for a drug for a serious or life-threatening illness that provides meaningful therapeutic advantage over existing treatments.
Categorie: Istituzioni

FDA Approves First Treatment for Patients with Plasminogen Deficiency, a Rare Genetic Disorder

Food and Drug Administration - Ve, 04/06/2021 - 22:32
FDA approved Ryplazim (plasminogen, human-tmvh) for the treatment of patients with type 1 plasminogen deficiency, also referred to as hypoplasminogenemia.
Categorie: Istituzioni

Coronavirus (COVID-19) Update: June 4, 2021

Food and Drug Administration - Ve, 04/06/2021 - 21:45
Coronavirus (COVID-19) Update: June 4, 2021
Categorie: Istituzioni

FDA Approves New Drug Treatment for Chronic Weight Management, First Since 2014

Food and Drug Administration - Ve, 04/06/2021 - 20:17
FDA approves Wegovy (semaglutide) injection for chronic weight management in adults with obesity or overweight with at least one weight-related condition.
Categorie: Istituzioni

FDA In Brief: FDA provides new guidance to further enhance the security of prescription drugs in the U.S. supply chain

Food and Drug Administration - Gi, 03/06/2021 - 16:29
FDA provides guidance to help ensure that prescription drugs are identified and traced properly as they move through the supply chain.
Categorie: Istituzioni

FDA Alerts Health Care Providers to Stop New Implants of Certain Ventricular Assist Device System

Food and Drug Administration - Gi, 03/06/2021 - 15:40
FDA is alerting health care providers to no longer implant end-stage heart failure patients with Medtronic’s Heartware Ventricular Assist Device (HVAD) System.
Categorie: Istituzioni

FDA Authorizes Marketing of Diagnostic Aid for Autism Spectrum Disorder

Food and Drug Administration - Me, 02/06/2021 - 17:09
FDA has authorized marketing of a device to help diagnose autism spectrum disorder (ASD). The Cognoa ASD Diagnosis Aid is a machine learning-based software intended to help health care providers diagnose ASD in children 18 months through 5 years of age who exhibit potential symptoms.
Categorie: Istituzioni

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

Food and Drug Administration - Ma, 01/06/2021 - 22:36
Coronavirus (COVID-19) Update: June 1, 2021
Categorie: Istituzioni

Nevada-Based Bottled Water Manufacturer Agrees to Stop Production for Failure to Comply with Manufacturing Requirements

Food and Drug Administration - Ma, 01/06/2021 - 21:47
Nevada-Based Bottled Water Manufacturer Agrees to Stop Production for Failure to Comply with Manufacturing Requirements
Categorie: Istituzioni

FDA Launches Challenge to Spur Development of Affordable Traceability Tools as Part of Broader Food Safety Efforts

Food and Drug Administration - Ma, 01/06/2021 - 17:03
FDA Launches Challenge to Spur Development of Affordable Traceability Tools as Part of Broader Food Safety Efforts
Categorie: Istituzioni

Coronavirus (COVID-19) Update: May 28, 2021

Food and Drug Administration - Ve, 28/05/2021 - 21:04
Coronavirus (COVID-19) Update: May 28, 2021
Categorie: Istituzioni

FDA Seeks $6.5 Billion to Further Investments in Critical Public Health Infrastructure, Core Food Safety and Medical Product Safety Programs

Food and Drug Administration - Ve, 28/05/2021 - 20:48
FDA seeks $6.5 billion as part of President’s 2022 budget, a nearly 8% increase over FY2021 funding.
Categorie: Istituzioni

FDA Approves First Targeted Therapy for Lung Cancer Mutation Previously Considered Resistant to Drug Therapy

Food and Drug Administration - Ve, 28/05/2021 - 19:04
The FDA approved the first targeted therapy for adult patients with non-small cell lung cancer whose tumors have a genetic mutation called KRAS G12C and who have received at least one prior systemic therapy.
Categorie: Istituzioni

Coronavirus (COVID-19) Update: FDA Authorizes Additional Monoclonal Antibody for Treatment of COVID-19

Food and Drug Administration - Me, 26/05/2021 - 23:39
The FDA issued an emergency use authorization for the investigational monoclonal antibody therapy sotrovimab for the treatment of mild-to-moderate COVID-19 in adult and pediatric patients.
Categorie: Istituzioni

FDA, FTC Warn Five Companies Illegally Selling Dietary Supplements Claiming to Treat Infertility

Food and Drug Administration - Me, 26/05/2021 - 19:13
FDA, FTC issues warning letters to five companies for illegally selling dietary supplements that claim to cure, treat, mitigate, or prevent infertility
Categorie: Istituzioni

FDA In Brief: FDA Announces Draft Guidances to Help Increase Transparency, Assist Reporting and Timely Completion for Certain Medical Device Studies after FDA Approval or Clearance

Food and Drug Administration - Me, 26/05/2021 - 15:41
Both guidances will assist stakeholders with post-approval study requirements and postmarket surveillance plans as well as the FDA policy of publishing data.
Categorie: Istituzioni
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