Coronavirus (COVID-19) Update

Today, the FDA approved Cabenuva as the first injectable, complete regimen for HIV-infected adults that is administered once a month.

Coronavirus (COVID-19) Update

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.

Coronavirus (COVID-19) Update

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)

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.

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.

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.

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.

The U.S. Food and Drug Administration has conditionally approved Laverdia-CA1 (verdinexor), the first oral tablet for treatment of canine lymphoma.

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

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.

Coronavirus (COVID-19) Update

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

FDA releases a new draft guidance on investigational new drug (IND) submissions for individualized ASO drug products.

Coronavirus (COVID-19) Update

Coronavirus (COVID-19) Update

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.

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.