ECRM_1170x120_1-10-22

FDA

CHPA Educational Foundation launches Interactive dietary supplement facts label

CHPA Educational Foundation launches Interactive dietary supplement facts label

WASHINGTON — With a growing number of Americans taking dietary supplements for self-care and preventive health management, the Consumer Healthcare Products Association (CHPA) Educational Foundation launched an interactive Supplement Facts label on its consumer-facing website KnowYourOTCs.org to highlight for shoppers what information they can find on a Supplement Facts label. All dietary supplements are required by

FDA expands Pfizer boosters for more teens

FDA expands Pfizer boosters for more teens

WASHINGTON — The U.S. is expanding COVID-19 boosters as it battles the omicron surge, with the Food and Drug Administration allowing extra Pfizer shots for children as young as 12. Boosters already are recommended for everyone 16 and older, and federal regulators on Monday decided they’re also warranted for 12- to 15-year-olds once enough time

FDA authorizes first oral antiviral for treatment of COVID-19

FDA authorizes first oral antiviral for treatment of COVID-19

WASHINGTON— U.S. health regulators on Wednesday authorized the first pill against COVID-19, a Pfizer drug that Americans will be able to take at home to head off the worst effects of the virus. The U.S. Food and Drug Administration issued an emergency use authorization (EUA) for Pfizer’s Paxlovid (nirmatrelvir tablets and ritonavir tablets, co-packaged for

FDA okays COVID vaccine boosters for all adults

FDA okays COVID vaccine boosters for all adults

WASHINGTON — The Food and Drug Administration has moved to expand its emergency authorization of Pfizer’s and Moderna’s COVID-19 vaccine booster shots to all adults, the companies announced Friday, as health officials are clamoring to head off a potential new surge of cases this winter. The Centers for Disease Control and Prevention must also weigh in with its recommendations before

FDA advisers back Pfizer/BioNTech COVID-19 vaccine for children

FDA advisers back Pfizer/BioNTech COVID-19 vaccine for children

WASHINGTON – An expert panel on Tuesday voted overwhelmingly to recommend the U.S. Food and Drug Administration authorize the Pfizer and BioNTech SE COVID-19 vaccine for children ages 5 to 11, saying the benefits of inoculation outweigh the risks. An authorization for that age group would be would be an important regulatory step toward reaching

CHPA issues statement on FDA’s O-T-C hearing aids proposed rule

CHPA issues statement on FDA’s O-T-C hearing aids proposed rule

WASHINGTON — The Consumer Healthcare Products Association (CHPA) issued the following statement from Marcia Howard, vice president, Scientific and Regulatory Affairs, upon the U.S. Food and Drug Administration (FDA) issuance of a Proposed Rule and Draft Guidance for establishing a regulatory category for over-the-counter (OTC) hearing aids: “CHPA applauds FDA for issuing this long-awaited proposed rule which

FDA expected to okay ‘mix and match’ strategy for boosters

FDA expected to okay ‘mix and match’ strategy for boosters

WASHINGTON — According to published reports, the Food and Drug Administration will soon allow Americans to receive a booster shot of COVID-19 vaccine different from their original dose. The federal drug regulator is expected to announce the so-called “mix and match” strategy on Wednesday when it officially authorizes boosters of the two-dose Moderna and single-shot

FDA to approve COVID-19 booster shots for immunocompromised people

FDA to approve COVID-19 booster shots for immunocompromised people

NEW YORK— According to published reports, the Food and Drug Administration is expected to approve COVID-19 vaccine booster shots this week. The FDA amendment of the emergency use authorizations for the Pfizer and Modern vaccines would allow anyone with compromised immune systems to get a third dose. The move, which could come as early as today, comes after

NACDS praises FDA approval of interchangeable biosimilar

NACDS praises FDA approval of interchangeable biosimilar

Editor’s note: The National Association of Chain Drug Stores (NACDS) published the following article on their website on the Food and Drug Administration (FDA) approval Semglee as the first interchangeable biosimilar product: In an historic move last week, the Food and Drug Administration (FDA) approved Semglee (insulin glargine-yfgn) as the first interchangeable biosimilar product. With this approval,

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