FDA committed to helping the people of the Democratic Republic of Congo effectively confront and end the current Ebola virus outbreak
Category Archives: Food Safety News
Statement from FDA Commissioner Scott Gottlieb, M.D., on the signing of the Right to Try Act
FDA stands ready to implement the Right to Try Act in a way that achieves Congress’ intent to promote access and protect patients
FDA approves new treatment for moderately to severely active ulcerative colitis
FDA today expanded the approval of Xeljanz (tofacitinib) to include adults with moderately to severely active ulcerative colitis.
As part of efforts to combat opioid crisis, FDA launches innovation challenge to spur development of medical devices ‒ including digital health and diagnostics ‒ that target pain, addiction and diversion
As part of efforts to combat opioid crisis, FDA launches innovation challenge to spur development of medical devices ‒ including digital health and diagnostics ‒ that target pain, addiction and diversion
FDA approves a new treatment for PKU, a rare and serious genetic disease
The FDA today approved Palynziq (pegvaliase-pqpz) for adults with a rare and serious genetic disease known as phenylketonuria (PKU).
FDA permits marketing of artificial intelligence algorithm for aiding providers in detecting wrist fractures
FDA permits marketing of artificial intelligence algorithm for aiding providers in detecting wrist fractures
FDA takes action against the use of OTC benzocaine teething products due to serious safety risk, lack of benefit
OTC oral health products containing benzocaine for the temporary relief of sore gums due to teething in infants or children should no longer be marketed. FDA is asking companies to stop selling these products for such use and requesting that companies add new warnings to all other benzocaine oral health products to describe certain serious risks.
Statement from FDA Commissioner Scott Gottlieb, M.D., on new FDA actions to keep consumers safe from the harmful effects of sun exposure, and ensure the long-term safety and benefits of sunscreens
The FDA is announcing three new efforts as part of a comprehensive set of actions to advance the FDA’s framework for sun protection products ahead of this coming summer
FDA warns companies selling illegal, unapproved kratom products marketed for opioid cessation, pain treatment and other medical uses
FDA warns companies selling illegal, unapproved kratom products marketed for opioid cessation, pain treatment and other medical uses
FDA approves new drug for patients with chronic liver disease who have low blood platelets and are undergoing a medical procedure
FDA approves Doptelet (avatrombopag) to treat thrombocytopenia in adults with chronic liver disease who are scheduled to undergo a medical procedure.