Office of Generic Drugs updates key leadership positions
WASHINGTON — The Food and Drug Administration’s Center for Drug Evaluation and Research is providing an update to key leadership positions within the Office of Generic Drugs, the agency announced. OGD has made assignments, most of which are in an acting capacity, to key OGD subordinate office leadership positions in preparation for Oct. 1 — the beginning of Year 3 of GDUFA when GDUFA goal dates go into effect.
Rob Lionberger will lead the Office of Research and Standards, or ORS, which includes the Division of Therapeutic Performance and the Division of Quantitative Methods and Modeling. John Peters will lead the Office of Bioequivalence, or OB, which includes the three Divisions of Bioequivalence and the Division of Clinical Review. Jason Woo will lead the Office of Regulatory Operations, or ORO, which includes the Division of Filing Review, the Division of Labeling Review, the Division of Project Management, and the Division of Quality Management Systems. Keith Flanagan will remain as transition lead for the Office of Generic Drug Policy, or OGDP, which includes the Division of Policy Development and the Division of Legal and Regulatory Support. Kathleen “Cook” Uhl, M.D. will remain in her current role as acting director of OGD.
According to the FDA, these changes will strengthen OGD’s operations and allow the office to meet the evolving needs of generic drug review. It also will provide higher visibility within the Center and Agency to address generic drugs challenges, and better positions OGD to maximize its efficiency in meeting GDUFA requirements, as demonstrated by the formation of an Office of Research Standards and an Office of Generic Drug Policy.
Generic drugs make up nearly 85% of prescriptions filled in the United States and represent affordable access to treatment for many patients and consumers. These individuals depend on the FDA to ensure that generic drugs perform clinically in the same way as their brand-name counterpart drugs. Transforming OGD into a super office was a critical and necessary step in recognizing the importance of generic drugs to public health and the national economy, the agency said.
New prescription counter double-counts, stores data
LAKE FOREST, Ill. — A new tablet counter from Kirby Lester is looking to make dispensing the proper amount of medication faster. The new KL1Plus double counts the tablets it dispenses and can then store the count data for up to 10 years.
The tool is meant to streamline double counts for filling prescriptions like controlled medications, which pharmacies are required to count twice. If there’s a dispute about medication dispensed, pharmacists can access stored counts on the tool’s touchscreen.
"The KL1Plus's trackable double-count is a pharmacy's safety net against counting errors or customer complaints," Kirby Lester’s VP sales Dave Johnson. "Regardless of what brand of robot a pharmacy uses, the KL1Plus enhances that pharmacy's defenses. … One hundred percent of your orders are verified, counted and archived with automation."
The KL1Plus will be showcased by Kirby Lester at upcoming shows like NACDS Boston, the North Carolina Mutual Annual in Myrtle Beach and the Morris & Dickson M.A.D. Days of Summer in Austin, Texas.
Nestlé Pure Life launches Loyalty Rewards Program, encouraging healthier lifestyles
STAMFORD, Conn. — Nestlé Pure Life recently launched the Spanish-language Drink Better Live Better Rewards Program, as a part of the brand's ongoing efforts to encourage families to live healthier lives.
Nestlé Pure Life is giving consumers the chance to redeem points for rewards by purchasing specially marked packages of water and entering the code online. Points also can be redeemed by inviting friends to sign up for the program through a shared link, watching Water Wizard videos on the website and taking a short survey. Rewards include Nestlé Pure Life coupons, kids’ sports equipment, backpacks, gift cards, theme park tickets and more.
In addition, through the Nestlé Pure Life en Español's Facebook page, Latina moms will receive expert advice on how to help their families, as well as be encouraged to share advice online. For the second year in a row, the Nestlé Pure Life brand is teaming up with leading Latina nutritionist, Sylvia Meléndez Klinger. Meléndez Klinger will share easy ways to encourage children to drink more water, and guidance on keeping kids hydrated in the summer, when returning to school and over the holidays.