FDA

U.S. Food & Drug Administration News: FDA approves new DNA-based test to determine blood compatibility

SILVER SPRING, MD – The U.S. Food and Drug Administration today approved ID CORE XT, a molecular-based assay used in blood transfusion medicine to help determine blood compatibility.  The assay can be used to determine blood donor and patient non-ABO red blood cell (RBC) types.  ID CORE XT is the second molecular assay approved for … Continue reading U.S. Food & Drug Administration News: FDA approves new DNA-based test to determine blood compatibility

U.S. Food & Drug Administration News: FDA approves first treatment for advanced form of the second most common skin cancer

SILVER SPRING, MD – The U.S. Food and Drug Administration today approved Libtayo (cemiplimab-rwlc) injection for intravenous use for the treatment of patients with metastatic cutaneous squamous cell carcinoma (CSCC) or locally advanced CSCC who are not candidates for curative surgery or curative radiation.  This is the first FDA approval of a drug specifically for … Continue reading U.S. Food & Drug Administration News: FDA approves first treatment for advanced form of the second most common skin cancer

U.S. Food & Drug Administration News: FDA provides update on its ongoing investigation into valsartan products

WASHINGTON – The U.S. Food and Drug Administration is updating the public on the agency’s ongoing investigation surrounding the recent voluntary recall of several drug products containing the active pharmaceutical ingredient (API) valsartan, used to treat high blood pressure and heart failure. The FDA’s latest testing of products shows an additional unexpected impurity in three … Continue reading U.S. Food & Drug Administration News: FDA provides update on its ongoing investigation into valsartan products

FDA News: Statement from Commissioner Scott Gottlieb, M.D. to support the development of novel nicotine replacement drug therapies to help smokers stop smoking

SILVER SPRING, MD – As a public health agency, there is no greater impact we can have to improve the health of our nation than to significantly reduce the rate of tobacco-related disease and death.  Through the U.S. Food and Drug Administration’s comprehensive framework for regulating nicotine and tobacco, we’re developing policies that support the … Continue reading FDA News: Statement from Commissioner Scott Gottlieb, M.D. to support the development of novel nicotine replacement drug therapies to help smokers stop smoking

NEW YORK | Soy “milk” makers may need to find alternative description

NEW YORK  — Soy and almond drinks that bill themselves as “milk” may need to consider alternative language after a top regulator suggested the agency may start cracking down on use of the term. The Food and Drug Administration signaled plans to start enforcing a federal standard that defines “milk” as coming from the “milking … Continue reading NEW YORK | Soy “milk” makers may need to find alternative description

FDA News: FDA announces voluntary recall of several medicines containing valsartan following detection of an impurity

SILVER SPRINGS, MD – The U.S. Food and Drug Administration (FDA) is alerting health care professionals and patients of a voluntary recall of several drug products containing the active ingredient valsartan, used to treat high blood pressure and heart failure.  This recall is due to an impurity, N-nitrosodimethylamine (NDMA), which was found in the recalled … Continue reading FDA News: FDA announces voluntary recall of several medicines containing valsartan following detection of an impurity

FDA OKs 1st drug to treat smallpox, in case of terror attack

U.S. regulators have approved the first treatment for smallpox — a deadly disease that was wiped out four decades ago — in case the virus is used in a terror attack. Smallpox, which is highly contagious, was eradicated worldwide by 1980 after a huge vaccination campaign. But people born since then haven’t been vaccinated, and … Continue reading FDA OKs 1st drug to treat smallpox, in case of terror attack

FDA to more aggressively tackle disruptive drug shortages

The U.S. Food and Drug Administration wants to more aggressively fight medication shortages that recently have led to rationing of some drugs and disrupted hospital operations. The FDA said Thursday that it’s forming a task force to find ways to improve the supply of crucial drugs. It’s a new approach for the drug regulator, which … Continue reading FDA to more aggressively tackle disruptive drug shortages