PP_1170x120_10-25-21

FDA

HDA issues statement on FDA’s proposed national standards for licensure of distributors and 3PLs

HDA issues statement on FDA’s proposed national standards for licensure of distributors and 3PLs

ARLINGTON, Va. — The Healthcare Distribution Alliance (HDA) released the following statement on the U.S. Food and Drug Administration’s (FDA) proposed national licensure standards for distributors and third-party logistics providers (3PLs). HDA recently submitted public comments to FDA on the agency’s proposed standards, which are required to be established under the 2013 Drug Supply Chain Security Act (DSCSA).

More affordable hearing aids could be in stores soon with new FDA ruling

More affordable hearing aids could be in stores soon with new FDA ruling

WASHINGTON — On Tuesday, the U.S. Food and Drug Administration issued a final rule to improve access to hearing aids which may in turn lower costs for millions of Americans. This action establishes a new category of over-the-counter (O-T-C) hearing aids, enabling consumers with perceived mild to moderate hearing impairment to purchase hearing aids directly

FDA authorizes pharmacists to prescribe Paxlovid with certain limitations

FDA authorizes pharmacists to prescribe Paxlovid with certain limitations

WASHINGTON — The U.S. Food and Drug Administration on Wednesday revised the Emergency Use Authorization (EUA) for Paxlovid (nirmatrelvir and ritonavir), to authorize state-licensed pharmacists to prescribe Paxlovid to eligible patients, with certain limitations to ensure appropriate patient assessment and prescribing of Paxlovid. “The FDA recognizes the important role pharmacists have played and continue to play

FDA proposes licensing standards for drug wholesalers

FDA proposes licensing standards for drug wholesalers

More than 30 years ago, U.S. law mandated state licensure of prescription drug wholesale distributors, resulting in a patchwork of varying state requirements and practical burdens for multi-state businesses. In 2013, Congress passed the Drug Supply Chain Security Act (DSCSA), which was intended to strengthen the integrity of the pharmaceutical distribution supply chain and to

FDA authorizes second booster dose for COVID

FDA authorizes second booster dose for COVID

SILVER SPRING, Md. — The U.S. Food and Drug Administration authorized on Tuesday a second booster dose of either the Pfizer-BioNTech or the Moderna COVID-19 vaccines for older people and certain immunocompromised individuals. The FDA previously authorized a single booster dose for certain immunocompromised individuals following completion of a three-dose primary vaccination series. This action

FDA concedes in compounding MOU litigation

FDA concedes in compounding MOU litigation

ALEXANDRIA, Va. — In a significant legal victory for pharmacy compounders, the U.S. Food & Drug Administration has conceded that it must conduct formal notice-and-comment rulemaking to implement its memorandum of understanding with states regarding interstate shipments of compounded medications. The agency concession is related to a lawsuit, Wellness Pharmacy v. Azar, brought in federal court against

Dr. Califf confirmed as FDA chief

Dr. Califf confirmed as FDA chief

WASHINGTON — The Senate on Tuesday narrowly confirmed Dr. Robert Califf as commissioner of the Food and Drug Administration, a key federal agency that has been without a permanent chief for more than a yearlong stretch of the coronavirus pandemic. The vote was 50-46, with six Republicans crossing the aisle to support him while five Democrats opposed

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

1 2 3 6
Adheris Health