SILVER SPRING, Md. — Pancreatic cancer patients will now have a new treatment option. The Food and Drug Administration has approved the use of AstraZeneca’s Lynparza for patients with tumors that didn’t grow after 16 weeks of chemotherapy. The drug is currently used to treat ovarian and breast cancer. Pancreatic cancer is the third largest cause
There is a growing public focus on the potential for legitimate pharmacological uses of cannabis. Much of this focus has been directed toward medical marijuana — the use of marijuana in plant form or its basic extracts. Although some states have legalized its use, the Food and Drug Administration has not approved marijuana in plant
WASHINGTON – Food Marketing Institute (FMI) on Friday participated in the Food and Drug Administration’s (FDA) public hearing regarding products containing cannabis or cannabis-derived compounds, including hemp and cannabidiol (CBD), as the agency considers whether and how to create a legal pathway for such products. FMI both conveyed the seriousness of the regulatory ambiguity facing its
WASHINGTON — In response to a statement published by Scott Gottlieb, Commissioner, Food and Drug Administration on February 11, the Council for Responsible Nutrition (CRN), the leading trade association for the dietary supplement and functional food industry, issued the following statement: Statement by Steve Mister, president and chief executive officer at CRN: “CRN appreciates the
SILVER SPRING, Md. — Yesterday, FDA Commissioner Scott Gottlieb issued the following statement on the signing of the Agriculture Improvement Act and the agency’s regulation of products containing cannabis and cannabis-derived compound: “Today, the Agriculture Improvement Act of 2018 was signed into law. Among other things, this new law changes certain federal authorities relating to
SILVER SPRING, Md. — Seeking to curb vaping by minors, the Food and Drug Administration is banning retail sales of most flavored e-cigarettes. FDA Commissioner Scott Gottlieb early this month was on the verge of announcing the prohibition (which will exempt menthol and mint flavors), as well as imposing age-verification requirements for online e-cigarette sales.
SEATTLE — Amazon.com has hired Taha Kass-Hout, the Food and Drug Administration’s first chief health informatics officer, according to published reports. Kass-Hout will serve in a business development role with the company’s Amazon Grand Challenge team, the reports say, and will concentrate on developing projects for the health care market. His exact mission, like the
SILVER SPRING, Md. — The Food and Drug Administration has begun efforts to improve flu vaccine effectiveness, according to FDA commissioner Scott Gottlieb. In a statement released yesterday, Gottlieb cited less protection against the influenza A H3N2 virus as a chief reason for the low efficacy of the 2017-2018 flu vaccine. The Centers for Disease
WASHINGTON — In his first State of the Union speech, President Donald Trump renewed his pledge to reduce prescription drug prices, days after a former big pharma executive was sworn in as Secretary of Health and Human Services. Trump had stunned the pharmaceutical industry during his 2016 campaign by declaring that drug manufacturers were “getting
SILVER SPRINGS, Md. — The Food and Drug Administration has clamped down on hundreds of websites engaged in illegal sales of prescription drugs. The FDA said Monday that, in tandem with international regulatory and law enforcement agencies, actions were taken against more than 500 websites selling potentially dangerous, unapproved versions of prescription medicines — including
WASHINGTON — The fiscal 2018 U.S. budget issued by the Trump administration calls for steep cuts in health care and scientific research while heavily boosting defense spending and offering substantial tax cuts. Dubbed “A New Foundation for American Greatness,” the spending plan was touted as a “taxpayer first” budget by Mick Mulvaney, director of the
WASHINGTON — Dr. Scott Gottlieb has been sworn in as the new commissioner of the Food and Drug Administration. Gottlieb, nominated as FDA commissioner by President Donald Trump in March, took the helm as the FDA’s 23rd commissioner on Thursday after being confirmed by a vote of 57-42 in the Senate late Tuesday. He takes
SILVER SPRING, Md. — The Food and Drug Administration has issued a warning that homeopathic teething tablets and gels may present a health risk to infants and children. The FDA on Friday urged consumers to stop using the products and dispose of any that they have. The agency said the homeopathic teething tablets and gels
WASHINGTON — Over-the-counter consumer antiseptic soaps with certain active ingredients can no longer be marketed, according to a final rule issued by the Food and Drug Administration. The FDA said the final rule, published Tuesday, applies to consumer antibacterial hand and body wash products containing one or more of 19 active ingredients, including triclosan and
