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 will
WASHINGTON — The Council for Responsible Nutrition (CRN), the leading trade association for the dietary supplement and functional food industry, announced Wednesday it filed comments with FDA calling for the agency to respond to its citizen petition on the status of products containing N-acetyl-L-cysteine (NAC). CRN expressed its dissatisfaction with the agency’s most recent response, provided
WASHINGTON — The Council for Responsible Nutrition (CRN), the leading trade association for the dietary supplement and functional food industry, responded Wednesday to FDA’s November 2021 decision not to address CRN’s citizen petition regarding N-acetyl-L-cysteine (NAC) on a timely basis, calling on the agency for swift review of the legal questions CRN raised. Instead, FDA dodged
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Scientific and Regulatory Affairs, upon the U.S. Food and Drug Administration (FDA) issuance of a Proposed Rule and Draft Guidance for establishing a regulatory category for over-the-counter (OTC) hearing aids: “CHPA applauds FDA for issuing this long-awaited proposed rule which has the
WASHINGTON — The Food and Drug Administration reported on Monday that it has granted full approval to Pfizer and BioNTech for their COVID-19 vaccine to be given to Americans as young as 16, clearing the way for a wave of moves that health officials say could reverse a nationwide slowdown in the pace of first
The centrality of retail pharmacies in protecting the health of Americans was underscored earlier this month when the Department of Health and Human Services reached an agreement with a group of national retailers, regional chains and networks of independent drug stores to facilitate COVID-19 immunizations, after one or more vaccines receive Food and Drug Administration
CINCINNATI — Kroger Co. this month said that the Food and Drug Administration had authorized use of its COVID-19 Test Home Collection Kit, which includes a nasal swab, transport vial, instruction sheet, prepaid shipping label and packing materials for return shipment of the sample to a laboratory. The testing solution combines the safety and convenience
WARREN, N.J. — The Food and Drug Administration has approved Voltaren Arthritis Pain as an over-the-counter remedy for arthritis pain, GlaxoSmithKline said Tuesday. With the FDA’s approval, Voltaren Arthritis Pain becomes the first and only prescription strength, nonsteroidal anti-inflammatory (NSAID) topical gel for arthritis pain available O-T-C in the United States. Voltaren Gel, which GSK Consumer
NEW YORK — Pharmacy chains CVS, Walgreens and Rite Aid and other retailers are pulling heartburn medication Zantac and its store-brand versions from their shelves after the Food and Drug Administration (FDA) warned it had detected low levels of a cancer-causing chemical in samples of the drug. The actions follow the FDA’s release of a
BALTIMORE — The American Association of Homeopathic Pharmacists (AAHP) convened its inaugural industry summit here last month to celebrate recent gains in the marketplace while assessing the challenges suppliers face in engaging with regulators and earning consumers’ trust. “We have a responsibility to produce products of the highest quality so that consumers and families across
SILVER SPRING, Md. — Food and Drug Administration Commissioner Scott Gottlieb is resigning, effective in about a month. The 46-year-old Gottlieb, who has been commuting weekly to the FDA office here from his home in Connecticut, wants to spend more time with his family, an administration official told The Washington Post. Health and Human Services