Food and Drug Administration

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Coronavirus (COVID-19) Update: June 25, 2021

Sa, 26/06/2021 - 01:44
Coronavirus (COVID-19) Update
Categorie: Istituzioni

Coronavirus (COVID-19) Update: FDA Authorizes Drug for Treatment of COVID-19

Ve, 25/06/2021 - 00:56
The FDA authorized a drug for the treatment for the treatment of COVID-19 in hospitalized adults and pediatric patients who are receiving systemic corticosteroids and require supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO).
Categorie: Istituzioni

FDA In Brief: FDA Encourages Inclusion of Patients with Incurable Cancers in Oncology Clinical Trials Regardless of Prior Therapies

Gi, 24/06/2021 - 15:53
FDA released new draft guidance encouraging broadening clinical trials eligibility criteria to include patients with incurable cancers, regardless of prior therapies.
Categorie: Istituzioni

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

Ma, 22/06/2021 - 21:13
The FDA issued a Drug Safety Communication for hand sanitizers, warning that symptoms such as headache, nausea, and dizziness can occur after applying alcohol-based hand sanitizers to the skin and inhaling the vapors that linger; and issued a warning letter to a company selling an unapproved product
Categorie: Istituzioni

FDA Approves First Oral Blood Thinning Medication for Children

Lu, 21/06/2021 - 21:57
Today, the FDA approved Pradaxa oral pellets and capsules to treat children with blood clots directly after they have been treated with a blood thinner given by injection for at least five days, and to prevent recurrent clots among patients who completed treatment for their first clot.
Categorie: Istituzioni

FDA Approves a Nasal Antihistamine for Nonprescription Use

Gi, 17/06/2021 - 22:32
FDA approved a nasal antihistamine for nonprescription use through a process called a partial prescription to nonprescription switch.
Categorie: Istituzioni

FDA In Brief: FDA Announces Qualification of a Medical Device Development Tool to Help Assess Patient- Reported Outcomes with LASIK Surgery

Gi, 17/06/2021 - 19:41
The FDA qualified a medical device development tool to help assess individuals’ symptoms and satisfaction with vision associated with LASIK surgery.
Categorie: Istituzioni

FDA In Brief: FDA Issues Draft Guidance on Remanufacturing and Discussion Paper Seeking Feedback on Cybersecurity Servicing of Medical Devices

Gi, 17/06/2021 - 19:12
The draft guidance should clarify “remanufacturing” and recommendations for labeling devices intended to be serviced over their useful life. A discussion paper outlining cybersecurity challenges and opportunities with the servicing was also released.
Categorie: Istituzioni

Coronavirus (COVID-19) Update: June 15, 2021

Me, 16/06/2021 - 00:54
Coronavirus (COVID-19) Update: June 15, 2021
Categorie: Istituzioni

FDA Approves StrataGraft for the Treatment of Adults with Thermal Burns

Ma, 15/06/2021 - 20:25
FDA approved StrataGraft for the treatment of adult patients with thermal burns containing intact dermal elements (remaining deep skin layers) for which surgical intervention is clinically indicated (also referred to as deep partial thickness burns).
Categorie: Istituzioni

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

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

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

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

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

FDA Grants Accelerated Approval for Alzheimer’s Drug

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

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

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

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

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

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