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GPhA weighs in on FDA’s proposed quality metrics

BY David Salazar

WASHINGTON — The Food and Drug Administration is currently proposing a new quality metrics program to ensure safety and quality of generic drugs. In response to the proposed guidelines, the Generic Pharmaceutical Association’s SVP sciences and regulatory affairs, David Gaugh, issued a statement. 

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Though Gaugh and GPhA support risk-based inspections to improve quality of products, he also notes that the proposed rules may go too far. 
 
“The agency’s proposed quality metrics program exceeds its statutory authority and could require manufacturers to make significant and unsubstantiated changes with potential to disrupt the manufacturing process, making it harder to ensure timely access to safe and effective generic drugs,” Gaugh said. 
 
He noted that GPhA and other industry associations have urged the FDA in separate statements to avoid ambiguity in quality metrics and consider additional moves that would ensure that proposed changes won’t disrupt supply. Gaugh offers the example of a phased approach that would allow the FDA to maximize the knowledge both the industry and FDA can acquire while minimizing burdens on manufacturers. Gaugh says a phased approach would also allow manufacturers time to build infrastructure to comply with inspections. 
 
“A well-designed quality metrics program can lead to a proactive system where the FDA and industry can continue to collaborate and improve drug quality,” Gaugh said. “Working together, the industry and the FDA can refine quality metrics to help ensure that new treatments can be developed and that safe and effective generic drugs can continue to expand access and increase health savings for millions of people.” 

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Target’s Cyber Monday surge delivers biggest online sales day ever

BY Michael Johnsen

MINNEAPOLIS — The surge in Cyber Monday shoppers looking to take advantage of Target's 15% discount sitewide forced the retailer to "place some guests into virtual lines," the retailer stated Tuesday morning, acknowledging the shutdown on Monday.
 
“We knew there’d be a tremendous response to our 15% off sitewide offer, and the demand was even higher than we anticipated,” said Jason Goldberger, president of Target.com and mobile. “Early in the day, Target.com orders were coming in twice as fast as our busiest day ever. And by early in the night, Target had already surpassed the previous record for online sales — making Cyber Monday our biggest online sales day ever.” 
 
"As we experience spikes in traffic, our systems place guests in a queue and prompt them to access the site later," Target spokeswoman Jenna Reckshe told CNBC on Monday. "We apologize to guests who experience any delays, we appreciate their patience, and encourage them to try again in a few minutes by refreshing their browser."
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