Bloomberg: FDA reorganizes to optimize industry oversight
NEW YORK — The Food and Drug Administration is reorganizing its field team within the FDA’s Office of Regulatory Affairs with a new focus on specific product areas vs. oversight of activities based on geographic regions, Bloomberg reported Monday.
The refocusing “will make our field programs more modern and responsive to today’s threats and challenges, while making sure that we are taking a risk-based and science-based approach to our work,” reported Scott Gottlieb, now one week into his new role as FDA commissioner, in an internal memo obtained by Bloomberg. “We need to make sure that we are achieving the greatest degree of consumer protection with the resources that we have."
The Natural Products Association on Tuesday expressed its support of the reorganization and applauded commissioner Gottlieb for his efforts to modernize the agency.
“The most effective way to oversee the supplement industry is to enforce the current law and aggressively pursue criminals that break it,” stated Dan Fabricant, president and CEO of NPA. “We applaud Dr. Gottlieb’s commitment to modernizing the FDA and making it more responsive to the consumers and manufacturers of dietary supplements and natural products.”
The initiative was proposed four years ago, with implementation set to start this month, Bloomberg reported.
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Single application earwax removal solution launched through Amazon
FORT WORTH, Texas — Eosera on Tuesday launched their earwax dissolving product, Earwax MD, through Amazon Exclusives. The product comes in two sizes, a kit that includes a 15mL bottle and rinsing bulb, and a single 15mL bottle only.
"When I met with Amazon, we decided it would be wonderful to launch with them because they reach all consumers," stated Elyse Dickerson, CEO Eosera. "Our earwax solution will help people worldwide and Amazon is the first step. By bringing this novel innovation to market, our goal is to improve the lives of both doctors and patients by saving people time and money."
The product was first introduced to hearing aid centers and audiologists in April.
According to Eosera, Earwax MD is the healthcare industry's first earwax impaction solution to safely and effectively dissolve wax blockage in a single application. "Instead of having to dig out earwax, audiologists and hearing aid centers can now fit patients for hearing aids in one visit," she said.
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New clinical data supports efficacy of OTC PE treatment PreBoost
MIAMI — Veru Healthcare on Saturday announced positive results from a Phase 4 clinical study of its proprietary product PreBoost (topical 4% benzocaine wipes) for the management of premature ejaculation. Data showed that PreBoost wipes statistically and significantly improved both objective and subjective symptoms of PE when compared to placebo wipes.
Results were selected for inclusion in the American Urological Association’s Annual Meeting Press Conference, held Saturday morning in Boston. The data will also be shared during a podium presentation on May 16, Veru Healthcare noted.
“Premature ejaculation or PE is the most common sexual dysfunction, affecting one in four men, yet we have limited options that really help men manage it,” stated study investigator and presenter Ridwan Shabsigh, chairman surgery, SBH Health System and professor clinical urology at Weill-Cornell Medical School. “These data represent the first ever placebo-controlled clinical study of medicines available in this class of products.”
After treatment with PreBoost, 82% of men were no longer considered to have PE while being treated and reported a statistically significant better sense of control, confidence, satisfaction, pleasure, increased length of intercourse and reduced frustration. Treatment was well tolerated and no transference of product was reported.
“We’re excited about these clinical data and what our product can do for men who have really had no options and desire a simple solution to PE,” commented Mitchell Steiner, president and CEO Veru Healthcare. “These Phase 4 data represent the first clinical study ever to show clinical data of an OTC product for the management of premature ejaculation.”
This is really misleading, there has been a superior product on the market for 5 years. Promescent has a eutectic formula that leaves the man with more sensitivity while not transferring to the female partner. This supposed study has only 26 participants is not IRB certified and not statistically significant. Promescent is already well established and respected in the urological community and is also OTC.