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FDA: 2015 saw record generics approvals, OGD on track with GDUFA goals

BY David Salazar
SILVER SPRING, Md. — The year 2015 saw the highest number of approvals and tentative approvals of generic drugs ever at the Food and Drug Administration according to a new report released by the Office of Generic Drugs. 
 
The report notes that in 2015, the OGD granted 580 approvals and 146 tentative approvals, including 99 in December alone – the largest number of drug approvals given out in a single month. The report also highlights the changes that the Office of Generic Drugs has seen since the Generic Drug User Fee Amendments passed in 2012, giving the FDA additional funding to review and approve generic drugs. 
 
The OGD has currently met or exceeded measurable performance goals outlined in the GDUFA commitment letter, completing first actions on 84% of backlogged abbreviated new drug applications (those filed before Oct. 1, 2012) and 88% of backlogged prior approval supplements. 
 
“We are confident in OGD’s ability to meet our GDUFA goals,” OGD director Dr. Kathleen Uhl said in the report. “There is incredible momentum. We are proud of our accomplishments so far, and we in OGD and the other offices involved in generic drug review activities are enthusiastic about GDUFA Year 4.”
 
Since GDUFA passed, the OGD has worked to streamline its workflows to decrease approval time and it launched the an informatics platform that supports review, approval and management of ANDAs, supplemental ANDAs, controlled correspondence pertaining to generic drug development, facility inspections and user fee checks.  
 
The organization has also sought to improve its relations with the industry and stakeholders, holding a forum on regulatory education for the industry, offering a webinar about controlled correspondence for generic drug development and shared information about patents and exclusivity through its newsletter. 
 
As part of its efforts to connect with stakeholders, the OGD will hold a public meeting on May 20 to garner feedback about its regulatory initiatives and chart a path forwards. 
 
“Despite our progress, we have a lot more work to do, but we want to do this collaboratively,” Uhl said. “Achieving ambitious goals that work for the public health requires broad input from the public, including industry, the research community, lawmakers and other stakeholders. … “With our ongoing efforts — and strong public input — we are confident that 2016 and beyond will be as successful as 2015.”
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Adapt Pharma launches Narcan Now app

BY David Salazar
DUBLIN — Adapt Pharma, maker of Narcan (naloxone) Nasal Spray announced Thursday the launch of its smartphone app Narcan Now. The app provides patients information about how to recognize the signs and symptoms of an opioid overdose, an instructional video and  a three-step administration guide for Narcan Nasal Spray, as well as emergency services access. 
 
The app is available through the iTunes App Store for iOS devices and the Google Play store for Android devices. 
 
Adapt Pharma has made its Narcan Nasal Spray available at discounted public interest pricing to such qualifying group purchasers as law enforcement, first responders and community naloxone distribution programs. It is also offering a carton of the nasal spray to every high school in the United States. 
 
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NACDS unveils digital tools for Total Store Expo in Boston

BY Gina Acosta

ARLINGTON, Va. — Online resources are now available to help retailers and suppliers get the most out of the 2016 National Association of Chain Drug Stores (NACDS) Total Store Expo in Boston in August.

NACDS is offering state-of-the art online and mobile resources to help attendees make the most out of their experience at NACDS Total Store Expo. The NACDS Total Store Expo website, mobile app, and NACDS-TV offer resources including webinars, checklists, online planning tools, an online press room and other tools for retailers and supplies – all designed to optimize trade show opportunities.

"You get to book the meetings with everyone you want to meet with … everybody shows up. With NACDS, people do show up, they're interested in speaking with you, so you do save time and money," said Vincent Ouellette, sales & development business manager of Vic Store Fixtures.

Each year, NACDS' Total Store Expo attracts over 5,600 retailer – and supplier – attendees. Many conference participants have contributed their success to the accessibility and utilization of the NACDS Total Store Expo online resources that are most beneficial when used in planning in advance to attend.

The 2016 NACDS Total Store Expo is the industry's largest gathering of its most influential leaders. It is a combination of both strategic and tactical business meetings between existing and new trading partners and is attended by industry decision-makers. A trade show and senior-level conference blended into a powerful appointment-based show, retailers and suppliers will find innovative and cutting-edge programming designed to promote strategic and tactical collaboration across departments within their companies.  The conference provides companies with a unique opportunity to gain new insights into today's evolving marketplace, and set a course for the future.

To learn more about the 2016 NACDS Total Store Expo and its resources — and everything you can do to make the most of your experience — explore the official 2016 NACDS Total Store Expo site, tse.nacds.org.

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