Food and Drug Administration

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

Ven, 22/01/2021 - 21:42
Coronavirus (COVID-19) Update
Categorie: Istituzioni

FDA Approves First Extended-Release, Injectable Drug Regimen for Adults Living with HIV

Gio, 21/01/2021 - 22:23
Today, the FDA approved Cabenuva as the first injectable, complete regimen for HIV-infected adults that is administered once a month.
Categorie: Istituzioni

Coronavirus (COVID-19) Update: January 19, 2021

Mar, 19/01/2021 - 22:56
Coronavirus (COVID-19) Update
Categorie: Istituzioni

FDA Marks Historic Public Health Milestone with Finalization of Two Key Rules for Companies Seeking to Market New Tobacco Products

Mar, 19/01/2021 - 22:49
FDA finalized two foundational rules for the premarket review of new tobacco products. These final rules provide additional information on the minimum requirements for the content, format and review of premarket tobacco product applications (PMTAs) and substantial equivalence (SE) reports.
Categorie: Istituzioni

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

Ven, 15/01/2021 - 23:36
Coronavirus (COVID-19) Update
Categorie: Istituzioni

Federal judge enters consent decree against Washington state juice processor

Ven, 15/01/2021 - 20:18
The U.S. District Court for the Eastern District of Washington entered a consent decree between the FDA and Valley Processing, Inc., to stop distributing adulterated juice products until the company complies with the Federal Food, Drug, and Cosmetic Act (FD&C Act)
Categorie: Istituzioni

FDA Warns Firms to Remove Unauthorized E-liquid Products from Market in First Letters Issued to Manufacturers that Did Not Submit Premarket Applications by Deadline

Ven, 15/01/2021 - 19:58
FDA issued warning letters to firms manufacturing and operating websites selling flavored e-liquids advising that selling these products lacking premarket authorization is illegal, and therefore cannot be sold or distributed in the U.S.
Categorie: Istituzioni

FDA Grants First Conditional Approval Under Expanded Authority to Control Seizures in Dogs with Idiopathic Epilepsy

Gio, 14/01/2021 - 19:57
The U.S. Food and Drug Administration granted the first conditional approval under its expanded authority to KBroVet-CA1 (potassium bromide chewable tablets) to treat dogs with seizures associated with idiopathic epilepsy.
Categorie: Istituzioni

CBP, FDA Seize Counterfeit, Unauthorized E-Cigarettes

Mer, 13/01/2021 - 21:18
U.S. Customs and Border Protection officers at the Dallas Fort Worth International Airport working in conjunction with agents from the U.S. Food and Drug Administration announced today that they have seized over 33,681 units of e-cigarettes with a Manufacturer’s Suggested Retail Price of $719,453.
Categorie: Istituzioni

FDA Releases Artificial Intelligence/Machine Learning Action Plan

Mar, 12/01/2021 - 16:35
FDA has released the Artificial Intelligence/Machine Learning- Based Software as a Medical Device Action Plan which outlines FDA’s next steps towards advancing practical oversight for these issues.
Categorie: Istituzioni

FDA Conditionally Approves First Oral Tablet to Treat Lymphoma in Dogs

Lun, 11/01/2021 - 19:44
The U.S. Food and Drug Administration has conditionally approved Laverdia-CA1 (verdinexor), the first oral tablet for treatment of canine lymphoma.
Categorie: Istituzioni

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

Ven, 08/01/2021 - 21:28
Coronavirus (COVID-19) Update: January 8, 2021
Categorie: Istituzioni

FDA Issues Alert Regarding SARS-CoV-2 Viral Mutation to Health Care Providers and Clinical Laboratory Staff

Ven, 08/01/2021 - 17:47
FDA is alerting clinical laboratory staff and health care providers that it is monitoring the impact of viral mutations, including the variant from the United Kingdom, the B.1.1.7 variant, on authorized SARS-CoV-2 molecular tests, and that false negative results can occur with any molecular test.
Categorie: Istituzioni

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

Mar, 05/01/2021 - 20:56
Coronavirus (COVID-19) Update
Categorie: Istituzioni

FDA Statement on Following the Authorized Dosing Schedules for COVID-19 Vaccines

Mar, 05/01/2021 - 01:30
FDA Statement on Following the Authorized Dosing Schedules for COVID-19 Vaccines
Categorie: Istituzioni

FDA Takes Steps to Provide Clarity on Developing New Drug Products in the Age of Individualized Medicine

Lun, 04/01/2021 - 16:02
FDA releases a new draft guidance on investigational new drug (IND) submissions for individualized ASO drug products.
Categorie: Istituzioni

Coronavirus (COVID-19) Update: December 30, 2020

Mer, 30/12/2020 - 23:04
Coronavirus (COVID-19) Update
Categorie: Istituzioni

Coronavirus (COVID-19) Update: December 28, 2020

Lun, 28/12/2020 - 23:43
Coronavirus (COVID-19) Update
Categorie: Istituzioni

FDA Approves First Generic of Drug Used to Treat Severe Hypoglycemia

Lun, 28/12/2020 - 23:35
The FDA has approved the first generic of glucagon for injection for the treatment of severe hypoglycemia (very low blood sugar), which may occur in patients with diabetes mellitus.
Categorie: Istituzioni

FDA Takes Further Steps to Confront Opioid Crisis Through Risk Evaluation and Mitigation Strategy Programs

Mer, 23/12/2020 - 23:46
The FDA took further steps to strengthen the transmucosal immediate-release fentanyl (TIRF) REMS program with approval of modifications that which will ensure that the benefits of these drugs continue to outweigh the risks.
Categorie: Istituzioni