Food and Drug Administration

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FDA Approves First Interchangeable Biosimilar Insulin Product for Treatment of Diabetes

Me, 28/07/2021 - 23:18
FDA Approves First Interchangeable Biosimilar Insulin Product for Treatment of Diabetes; Availability Will Help Increase Access and Potentially Lower the Cost of Insulin for People with Diabetes
Categorie: Istituzioni

FDA In Brief: FDA Warns Firm with Over 15 Million Products Listed with FDA to Remove Unauthorized E-Cigarette Products from Market

Me, 28/07/2021 - 18:47
FDA issued a warning letter to Visible Vapors LLC advising that marketing its tobacco products without premarket authorization, is illegal, and they can’t be sold or distributed in the U.S.
Categorie: Istituzioni

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

Ve, 23/07/2021 - 22:04
Coronavirus (COVID-19) Update: July 23, 2021
Categorie: Istituzioni

Coronavirus (COVID-19) Update: July 20, 2021

Ma, 20/07/2021 - 22:35
Coronavirus (COVID-19) Update: July 20, 2021
Categorie: Istituzioni

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

Ve, 16/07/2021 - 22:28
Coronavirus (COVID-19) Update
Categorie: Istituzioni

FDA Grants First Full Approval for Treatment of Lymphoma in Dogs

Gi, 15/07/2021 - 19:49
The FDA fully approved a drug intended to treat lymphoma in dogs, making the drug the first conditionally approved new animal drug for dogs to achieve full FDA approval.
Categorie: Istituzioni

Coronavirus (COVID-19) Update: July 13, 2021

Ma, 13/07/2021 - 22:51
Coronavirus (COVID-19) Update: July 13, 2021
Categorie: Istituzioni

Coronavirus (COVID-19) Update: July 9, 2021

Ve, 09/07/2021 - 21:44
Coronavirus (COVID-19) Update: July 9, 2021
Categorie: Istituzioni

Joint CDC and FDA Statement on Vaccine Boosters

Ve, 09/07/2021 - 21:18
Joint CDC and FDA Statement on Vaccine Boosters
Categorie: Istituzioni

FDA In Brief: FDA Issues Systems Recognition Draft Guidance

Ve, 09/07/2021 - 19:09
This draft guidance explains how the agency plans to adjust its regulatory oversight activities for foods subject to FDA regulatory requirements when the foods are produced in or imported from other countries.
Categorie: Istituzioni

Coronavirus (COVID-19) Update: July 6, 2021

Ma, 06/07/2021 - 21:57
Coronavirus (COVID-19) Update: July 6, 2021
Categorie: Istituzioni

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

Ve, 02/07/2021 - 21:12
Coronavirus (COVID-19) Update
Categorie: Istituzioni

FDA Releases Cyclospora Prevention, Response and Research Action Plan

Gi, 01/07/2021 - 20:27
As part of our ongoing efforts to combat foodborne illness, the FDA released the Cyclospora Prevention, Response and Research Action Plan
Categorie: Istituzioni

FDA Approves Component of Treatment Regimen for Most Common Childhood Cancer

Gi, 01/07/2021 - 00:27
The FDA approved a drug as a component of a chemotherapy regimen to treat acute lymphoblastic leukemia and lymphoblastic lymphoma in adult and pediatric patients who are allergic to the E. coli-derived asparaginase products used most commonly for treatment.
Categorie: Istituzioni

FDA In Brief: FDA Revokes Emergency Use Authorizations for Certain Respirators and Decontamination Systems as Access to N95s Increases Nationwide

Me, 30/06/2021 - 22:31
FDA announced it is revoking EUAs of all non-NIOSH-approved disposable respirators, which includes imported disposable respirators such as KN95s, along with revoking EUAs for decontamination and bioburden reduction systems.
Categorie: Istituzioni

FDA Provides Update on Ongoing Efforts to Better Understand the Occurrence of PFAS in the Food Supply

Me, 30/06/2021 - 17:10
FDA Provides Update on Ongoing Efforts to Better Understand the Occurrence of PFAS in the Food Supply
Categorie: Istituzioni

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

Ma, 29/06/2021 - 22:28
The FDA has sent to Congress its Report on Drug Shortages for Calendar Year 2020, which includes a section on the agency’s drug shortage efforts in response to COVID-19. The FDA is also working to implement the drug shortage-related provisions of the Coronavirus Aid, Relief, & Economic Security Act.
Categorie: Istituzioni

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