SATIS_1170x120_1-25-21

FDA

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 will

CRN files comments with FDA on NAC

CRN files comments with FDA on NAC

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

CRN criticizes FDA’s ‘nonresponsive’ response

CRN criticizes FDA’s ‘nonresponsive’ response

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

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

CHPA’s 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Scientific and Regulatory Affairs, upon the U.S. Food and Drug Administration (FDA) issuance of a Proposed Rule and Draft Guidance for establishing a regulatory category for over-the-counter (OTC) hearing aids: “CHPA applauds FDA for issuing this long-awaited proposed rule which has the

It’s an apt time to give pharmacies their due

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

FDA approves GSK’s Voltaren Arthritis Pain for O-T-C use

FDA approves GSK’s Voltaren Arthritis Pain for O-T-C use

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

Chains pull Zantac from shelves

Chains pull Zantac from shelves

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

AAHP celebrates growth of homeopathy

AAHP celebrates growth of homeopathy

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