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Requests for “enforcement actions are not within the scope of FDA’s citizen petition procedures,” CDER says, rejecting petition dosing device firm Parenteral Technologies submitted as it prepares for workshop on Pediatric Research Equity Act requirements for OTC NDA sponsors.
CRN/Radicle Trailblazing Woman Award to ChromaDex’s Yasmeen Nkrumah-Elie; Nourish’s TV ad campaign features US soccer star Alex Morgan; Vitamin Shoppe BodyTech Elite Altered Strength line sponsors Team Red, White & Blues; contract pharma/consumer health product development firm LabConnect appoints Wesley Wheeler CEO; Avanos’ Game Ready is “Recovery Partner” of NFL’s Nick Bosa; Akita adds Robert Hanson to advisory board; and BODi has wrestler as brand ambassador
UK pharma also reaches agreement in principle, subject to DoJ approval, to pay $70m to resolve a whistleblower complaint filed by Valisure, the testing lab which in 2019 raised concerns about a potential link between the use of drugs containing ranitidine, a histamine-2 blocker, and cancer.
Country Life Vitamins launches healthy aging support line as it announces less than half of US consumers in a recent survey were aware of biological processes that affect aging. Groupe Berken and Arctic Biosciences partner to bring to North America herring caviar oil extract in a supplement designed to support optimal health across all life stages.
Regenerative Processing replaces nozzle to prevent backflow for its Regener-Eyes drops but FDA warning states numerous questions about sterility at the firm’s plant and about its procedures and systems for preventing microbial contamination.
After launching Retaine MGD Advanced, OcuSoft says a release by Bruder Healthcare referenced Retaine MGD trademark and statements from a previous OcuSoft announcement about the original product attributed to an optometrist. B+L, Rohto brand and homeopathic firm Relief Products also make US OTC eye care space moves.
Jessica Spence joins as North American president while CFO Dan Sullivan becomes COO and Francesca Weissman, finance and business strategy SVP, adds CFO to her title in latest executive office changes by the marketer of brands including Schick men's and women’s shaving, Playtex, Stayfree, Carefree and o.b. feminine care and Banana Boat and Hawaiian Tropic sun care.
Nonbinding forecast, fourth for the program, includes risks associated with codeine-containing cough medicine as a topic FDA will include in ongoing evaluation of GRASE for pediatric cough cold drug products marketed under monograph for cold, cough, allergy, bronchodilator and anti-asthmatic OTC drugs.
Brands also making market moves as lawmakers consider legislation instructing Transportation Security Administration to provide guidance to minimize risk for contamination of baby formula and related pediatric nutritional products.
Mucinex Sinus saline nasal spray is designed to treat sinus-related symptoms as “first-ever drug-free saline product” with a dual nozzle offering two spray settings, marketer Reckitt-Benckiser says.