FDA launches advisory committee membership nomination portal
SILVER SPRING, Md. — The Food and Drug Administration on Wednesday launched the advisory committee membership nomination portal, an online, interactive system that allows interested individuals to submit nominations for membership to any of the agency’s 33 advisory committees.
The portal will enable nominees to submit their application for membership on an advisory committee from the FDA’s website, creating a paperless, streamlined process that will enable the agency to accept, evaluate and ultimately nominate qualified individuals for membership in a timely fashion.
“The portal allows applicants to complete their entire application online,” Jill Hartzler Warner, acting associate commissioner of the FDA’s Office of Special Medical Programs, said. “Applicants will experience an interactive, step-by-step process that eliminates confusion and accelerates the timeframe for submitting and processing an application.”
The system will securely store all applicant information and enable the FDA to develop metrics for assessing the entire applicant pool to identify qualified candidates to fill specific vacancies on advisory committees. Currently, applications must either be emailed or mailed to the agency.
Nominations for scientific members and consumer and industry representatives may be submitted by professional societies, industry and consumer groups, and other interested persons and organizations. Potential candidates are asked to provide detailed information concerning such matters as financial holdings, employment and research grants and/or contracts in order to permit evaluation of possible sources of conflict of interest.
Advisory committees provide the FDA with independent, expert advice on a range of complex scientific, technical and policy issues.
J&J’s return to market of several iconic OTC brands a success
NEW BRUNSWICK, N.J. — McNeil Consumer Healthcare has returned approximately 75% of its OTC portfolio to store shelves, Alex Gorsky, Johnson & Johnson chairman and CEO told analysts Tuesday. "Growth in the consumer segment was achieved in part as a result of our success in restoring a reliable supply of OTC products to the United States marketplace, and we’re starting to see them gain traction as well, once they’re back in the market," he said. Gorsky outlined a number of brands that have grown J&J’s U.S. OTC business by 21.6%, including Neutrogena, Listerine, Tylenol and Motrin.
"And we’re going to continue backing these brands with strong scientifically based and endorsed claims to differentiate them in the marketplace," he added. "We’re also investing in things like cross channel marketing across TV, print, social media, to really support their launch and do it in a benchmark way."
Customers have not held J&J’s production woes of several years ago against the company as it brings each brand back to market in a big way, Gorsky suggested. "We still have a substantial volume that we would have to make up to get back to the earlier volumes that we saw, but every time we introduce the product to the market, Extra Strength Tylenol, if you look at Children’s Tylenol, Children’s Motrin, pediatric, we’re seeing customers respond," he said. "The other factor is, though, we’re very pleased with the partnership that’s been taking place with our major trade partners. So all the major outlets have been enthusiastic about working with us to get these brands back on the shelves."
Study: Cranberry concentrate supplements reduce bladder infections
OUD-BEIJERLAND, The Netherlands — New research published in the American Journal of Geriatrics on Monday found that more than 25% of bladder infections (cystitis) can be reduced with the regular use of cranberry concentrate supplements in vulnerable older people in nursing homes at high risk of urinary tract infections.
More than 20% of these high-risk elderly did not develop any UTI’s at all when taking the cranberry capsule.
The Public Health and Primary Care department of the Leiden University Medical Center LUMC conducted the one-year study in 21 Dutch nursing homes and was financed by ZonMW, a government organization that funds health research to help improve health and health care in the Netherlands, and by the supplier of cranberry concentrate Springfield Nutraceuticals.
Currently, nearly 1-in-10 nursing home residents in the United States have a urinary tract infection. An estimated 17% to 69% of all catheter-associated urinary tract infections may be preventable.
In the one-year study, 928 people with an average age of 85 years participated. During the study, cranberry capsules with a specific composition were used and compared with a placebo. In this study the cranberry supplement used contains the whole cranberry: skin, seeds, pulp, juice and fiber that previous research has shown is preferable to those that do not contain the whole fruit.