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

FDA authorized the marketing of four new Verve oral tobacco products manufactured by U.S. Smokeless Tobacco Company LLC.

FDA issued a proposed rule to establish a new category of over-the-counter hearing aids. When finalized, the rule would allow hearing aids that fall within this category to be sold directly to consumers in stores or online without a medical exam or a fitting by an audiologist.

The U.S. Food and Drug Administration today approved the first interchangeable biosimilar product to treat certain inflammatory diseases. Cyltezo (adalimumab-adbm) is now approved as interchangeable with (and may be substituted for) its reference product Humira (adalimumab).

Coronavirus (COVID-19) Update

The FDA is announcing an upcoming meeting of its Antimicrobial Drugs Advisory Committee (AMDAC) to discuss Merck and Ridgeback’s Application for the Emergency Use of a COVID-19 Oral Treatment

Today, the U.S. Food and Drug Administration announced it has awarded 11 new clinical trial research grants, equaling more than $25 million of funding over the next four years.

FDA Issues Final Guidance to Food Industry for Voluntarily Reducing Sodium in Processed and Packaged Foods

Coronavirus (COVID-19) Update: October 12, 2021

FDA authorized the marketing of three new tobacco products, marking the first set of electronic nicotine delivery system (ENDS) products ever to be authorized by the agency through the Premarket Tobacco Product Application (PMTA) pathway.

The FDA is withdrawing the temporary policies outlined in the guidances for the preparation of certain alcohol-based hand sanitizer products and alcohol for use in hand sanitizers

FDA approves Rethymic for immune reconstitution in pediatric patients with congenital athymia which is the first thymus tissue product approved in the U.S.

Coronavirus (COVID-19) Update

FDA is warning the public and health care professionals not to use needle-free devices commonly referred to as dermal fillers or fillers.

FDA issues final order reclassifying surgical staplers for internal use requiring them to undergo premarket review, final guidance for labeling requirements for patient risk communication and a letter to health care providers to increase their safe use.

The FDA announced that California, Florida, Utah and Wisconsin have entered into domestic mutual reliance agreements with the agency

FDA issued warning letters to 20 companies for continuing to unlawfully market e-cigarette products with Marketing Denial Orders.

FDA is revising its Hospital and Health System Compounding Guidance to Help Preserve Patient Access to Compounded Drugs

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

FDA issued an emergency use authorization (EUA) for the ACON Laboratories Flowflex COVID-19 Home Test, an over-the-counter (OTC) COVID-19 test, which adds to the growing list of tests that can be used at home without a prescription.