WASHINGTON — The Food and Drug Administration on Thursday approved the oral contraceptive Opill for over-the-counter sales, making it the first hormonal contraceptive pill available in the U.S. without a prescription. The approval marks a major win for medical groups, including the American Medical Association and the American College of Obstetricians and Gynecologists, which have
WASHINGTON — The Consumer Healthcare Products Association (CHPA) released the following statement in advance of FDA Advisory Committee meetings considering OTC access to naloxone: “Over-the-counter (O-T-C) availability of naloxone – a life-saving emergency therapy for opioid overdoses that is currently only available with a prescription (Rx) – would be a critical step forward in public
NEW YORK — With family planning rights under major threat in several states, the Food and Drug Administration (FDA) announced this week a move to expand access to abortion. Now chains such as CVS and Walgreens will be able to sell abortion pills to those with prescriptions. The FDA gave the green light to mifepristone
VAUGHAN, Ontario – Bausch + Lomb Corp. announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for Biotrue Hydration Boost Contact Lens Rehydrating drops, a preservative-free multi-dose rehydrating drop for use with soft and rigid gas permeable contact lenses. “We are proud to continue to build upon our successful
WASHINGTON – The National Grocers Association (NGA), which represents independent supermarket operators, issued a statement on Wednesday contending that a proposed Food and Drug Administration rule on food traceability would disproportionately hurt small grocers. The trade group notes that the proposed rule aims to establish additional traceability recordkeeping requirements for persons who manufacture, process, pack
(Left to right): U.S. Commissioner of Food and Drugs, Dr. Robert Califf; Walgreens pharmacist Chuckwuma ‘Chuks’ Onwuka; U.S. Secretary of Health and Human Services Xavier Becerra; and U.S. Senator Elizabeth Warren (D-MA) visit a Walgreens pharmacy in Washington, D.C., on October 19, 2022, as hearing aids go over the counter for the first time. ARLINGTON,
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