Food and Drug Administration

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FDA Authorizes Marketing of Diagnostic Aid for Autism Spectrum Disorder

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

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

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

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

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

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

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

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

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

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

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

Ma, 25/05/2021 - 22:13
Coronavirus (COVID-19) Update: May 25, 2021
Categorie: Istituzioni

FDA Announces Seizure of Adulterated Dietary Supplements Containing Kratom

Ve, 21/05/2021 - 23:36
FDA announced that U.S. Marshals, at the agency’s request, seized more than 207,000 units of dietary supplements and bulk dietary ingredients that are or contain kratom, including over 34,000 kilograms of bulk kratom.
Categorie: Istituzioni

Coronavirus (COVID-19) Update: May 21, 2021

Ve, 21/05/2021 - 22:35
The FDA updated the definition of high risk for COVID-19 to include additional medical conditions and factors associated with increased risk for progression to severe disease.
Categorie: Istituzioni

FDA Approves First Targeted Therapy for Subset of Non-Small Cell Lung Cancer

Ve, 21/05/2021 - 18:48
The FDA approved the first treatment for adult patients with non-small cell lung cancer whose tumors have specific types of genetic mutations called EGFR exon 20 insertion mutations.
Categorie: Istituzioni

FDA In Brief: FDA Solicits Public Feedback on Discussion Paper as Part of its Ongoing Commitment to Patient Safety

Gi, 20/05/2021 - 18:39
FDA publishes a discussion paper to solicit feedback on the scope of device-related materials information and the ways it could be communicated to the intended users.
Categorie: Istituzioni

FDA In Brief: FDA Solicits Public Feedback on Discussion Paper as Part of its Ongoing Commitment to Patient Safety

Gi, 20/05/2021 - 18:39
FDA publishes a discussion paper to solicit feedback on the scope of device-related materials information and the ways it could be communicated to the intended users.
Categorie: Istituzioni

FDA In Brief: FDA Alerts Patients and Health Care Providers About Possible Problems with Mammograms Performed at Capitol Radiology LLC

Gi, 20/05/2021 - 18:19
FDA issues safety communication at Capitol Radiology LLC, also known as Laurel Radiology Services, in Laurel, Maryland.
Categorie: Istituzioni

FDA In Brief: FDA Alerts Patients and Health Care Providers About Possible Problems with Mammograms Performed at Capitol Radiology LLC

Gi, 20/05/2021 - 18:19
FDA issues safety communication at Capitol Radiology LLC, also known as Laurel Radiology Services, in Laurel, Maryland.
Categorie: Istituzioni

FDA In Brief: FDA Authorizes Longer Time for Refrigerator Storage of Thawed Pfizer-BioNTech COVID-19 Vaccine Prior to Dilution, Making Vaccine More Widely Available

Me, 19/05/2021 - 23:45
FDA authorized undiluted, thawed Pfizer-BioNTech COVID-19 Vaccine vials to be stored in the refrigerator at 2°C to 8°C (35°F to 46°F) for up to 1 month.
Categorie: Istituzioni

FDA In Brief: FDA Issues Draft Guidance on Early Clinical Studies for Certain Medical Devices to Improve Glycemic Control for Type 2 Diabetes

Me, 19/05/2021 - 18:51
FDA issued a draft guidance with recommendations for feasibility and early feasibility clinical studies for devices intended to improve glycemic control in patients with Type 2 diabetes.
Categorie: Istituzioni