We recognize that there is a high level of interest regarding FDA’s views on communications about medical products. We are committed to an ongoing dialogue with industry and other stakeholders, and, when needed, providing guidance to clarify the agency’s thinking on these issues. Today, the FDA released two separate draft guidances that will each help […]
Today, the U.S. Food and Drug Administration and the U.S. Environmental Protection Agency issued final advice regarding fish consumption. This advice is geared toward helping women who are pregnant or may become pregnant – as well as breastfeeding mothers and parents of young children – make informed choices when it comes to fish that are […]
The U.S. Food and Drug Administration today approved Spinraza (nusinersen), the first drug approved to treat children and adults with spinal muscular atrophy (SMA), a rare and often fatal genetic disease affecting muscle strength and movement. Spinraza is an injection administered into the fluid surrounding the spinal cord.
The U.S. Food and Drug Administration today allowed marketing of a new tissue expander system for soft tissue expansion in two-stage breast reconstruction following mastectomy and in the treatment of underdeveloped breasts and soft tissue deformities. A patient uses a dose controller to independently inflate the expander.
The U.S. Food and Drug Administration today expanded the approved use of Dexcom’s G5 Mobile Continuous Glucose Monitoring System to allow for replacement of fingerstick blood glucose (sugar) testing for diabetes treatment decisions in people 2 years of age and older with diabetes.
The U.S. Food and Drug Administration today expanded the approved use of Dexcom’s G5 Mobile Continuous Glucose Monitoring System to allow for replacement of fingerstick blood glucose (sugar) testing for diabetes treatment decisions in people 2 years of age and older with diabetes.
The U.S. Food and Drug Administration today granted accelerated approval to Rubraca (rucaparib) to treat women with a certain type of ovarian cancer.
The U.S. Food and Drug Administration today granted accelerated approval to Rubraca (rucaparib) to treat women with a certain type of ovarian cancer.
The U.S. Food and Drug Administration today approved Eucrisa (crisaborole) ointment to treat mild to moderate eczema (atopic dermatitis) in patients two years of age and older.
The U.S. Food and Drug Administration today approved Eucrisa (crisaborole) ointment to treat mild to moderate eczema (atopic dermatitis) in patients two years of age and older.
The health of our nation’s children is a responsibility that the FDA takes very seriously. Parents and caregivers are often concerned when their young child requires a medical procedure for which anesthesia or sedation drugs are necessary. Understandably, there are many questions, including whether the drugs are safe for their child. Pregnant women who must […]
The health of our nation’s children is a responsibility that the FDA takes very seriously. Parents and caregivers are often concerned when their young child requires a medical procedure for which anesthesia or sedation drugs are necessary. Understandably, there are many questions, including whether the drugs are safe for their child. Pregnant women who must […]
The U.S. Food and Drug Administration today took action on the first applications reviewed through the modified risk tobacco product (MRTP) pathway for eight Swedish Match North America Inc. snus smokeless tobacco products sold under the General brand name. The agency denied the company’s request to remove a currently required warning stating that the products […]
The U.S. Food and Drug Administration today took action on the first applications reviewed through the modified risk tobacco product (MRTP) pathway for eight Swedish Match North America Inc. snus smokeless tobacco products sold under the General brand name. The agency denied the company’s request to remove a currently required warning stating that the products […]
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 […]
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 […]
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 […]
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 […]
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 […]