The U.S. Food and Drug Administration today approved Maci (autologous cultured chondrocytes on porcine collagen membrane) for the repair of symptomatic, full-thickness cartilage defects of the knee in adult patients. Maci is the first FDA-approved product that applies the process of tissue engineering to grow cells on scaffolds using healthy cartilage tissue from the patient’s own knee.

The U.S. Food and Drug Administration today issued warning letters to four tobacco manufacturers — Swisher International Inc., Cheyenne International LLC, Prime Time International Co. and Southern Cross Tobacco Company Inc. — for selling flavored cigarettes that are labeled as little cigars or cigars, which is a violation of the Family Smoking Prevention and Tobacco Control Act. The companies received warning letters for products under the “Swisher Sweets,” Cheyenne,” “Prime Time” and “Criss-Cross” brands in a variety of youth-appealing flavors, including grape, cherry, wild cherry and strawberry.

The U.S. Food and Drug Administration today announced important steps to better support consumer access to hearing aids. The agency issued a guidance document explaining that it does not intend to enforce the requirement that individuals 18 and up receive a medical evaluation or sign a waiver prior to purchasing most hearing aids. This guidance is effective immediately. Today, the FDA is also announcing its commitment to consider creating a category of over-the-counter (OTC) hearing aids that could deliver new, innovative and lower-cost products to millions of consumers.

The U.S. Food and Drug Administration today announced important steps to better support consumer access to hearing aids. The agency issued a guidance document explaining that it does not intend to enforce the requirement that individuals 18 and up receive a medical evaluation or sign a waiver prior to purchasing most hearing aids. This guidance is effective immediately. Today, the FDA is also announcing its commitment to consider creating a category of over-the-counter (OTC) hearing aids that could deliver new, innovative and lower-cost products to millions of consumers.

The U.S. Food and Drug Administration today approved a new indication for Jardiance (empagliflozin) to reduce the risk of cardiovascular death in adult patients with type 2 diabetes mellitus and cardiovascular disease.

The U.S. Food and Drug Administration announced today that the U.S. Marshals Service seized more than 4 million pounds of product produced by Valley Milk Products LLC (Valley Milk) of Strasburg, Virginia.

A new mouse model developed by scientists at the U.S. Food and Drug Administration may help in exploring the potential activity of Zika virus vaccines and therapeutics. Published today in PLoS Pathogens, is the description of a neonatal mouse model that provides a platform for potentially improving and expediting studies to understand the causes and effects (pathology) of the Zika virus.

A new mouse model developed by scientists at the U.S. Food and Drug Administration may help in exploring the potential activity of Zika virus vaccines and therapeutics. Published today in PLoS Pathogens, is the description of a neonatal mouse model that provides a platform for potentially improving and expediting studies to understand the causes and effects (pathology) of the Zika virus.

The U.S. Food and Drug Administration approved Intrarosa (prasterone) to treat women experiencing moderate to severe pain during sexual intercourse (dyspareunia), a symptom of vulvar and vaginal atrophy (VVA), due to menopause. Intrarosa is the first FDA approved product containing the active ingredient prasterone, which is also known as dehydroepiandrosterone (DHEA).

The U.S. Food and Drug Administration approved Intrarosa (prasterone) to treat women experiencing moderate to severe pain during sexual intercourse (dyspareunia), a symptom of vulvar and vaginal atrophy (VVA), due to menopause. Intrarosa is the first FDA approved product containing the active ingredient prasterone, which is also known as dehydroepiandrosterone (DHEA).