Navigation Links
ISPE Named as a Source in FDA Strategic Plan for Preventing and Mitigating Drug Shortages
Date:10/31/2013

TAMPA, Fla., Oct. 31, 2013 /PRNewswire-USNewswire/ -- ISPE's report on its 2013 Drug Shortages Survey was cited twice in the Strategic Plan for Preventing and Mitigating Drug Shortages released today by the US Food and Drug Administration (FDA). The plan also formalized the FDA's commitment to engaging with ISPE "to analyze data from a recent global survey ISPE conducted on the technical, scientific, manufacturing, quality, and compliance issues that have resulted in drug shortages."  Dr. Douglas Throckmorton, deputy director of the FDA's Center for Drug Evaluation and Research (CDER), said later on a teleconference with stakeholders, "We are looking forward to continuing to work with ISPE."

(Logo: http://photos.prnewswire.com/prnh/20120912/DC73253LOGO)  

Published in June 2013, the report on ISPE's Drug Shortages Survey is available at www.ISPE.org/Drug-Shortages/2013JuneReport. The comprehensive global survey revealed no single technical or manufacturing cause for drug shortages. Instead, initial data analysis showed:

  • Issues within the quality systems of manufacturing can lead to drug shortages.
  • Companies that have successfully avoided drug shortages focus on strong quality systems, and the involvement of company leadership is notable in those companies that avoid shortages. 
  • Improved regulatory interaction can mitigate the likelihood of a shortage.

"We are pleased that ISPE's work has been helpful to the FDA in its consideration of the challenges of addressing drug shortages," says Nancy S. Berg, President and CEO of ISPE. "The survey revealed many new opportunities for ISPE to facilitate dialogue throughout the industry, advancing our collective understanding of the causes of drug shortages and leading to process improvements that may mitigate or avoid them.  As a neutral organization focused on product quality and patient safety, ISPE is uniquely positioned to play this role."

Since the report's initial release the ISPE Drug Shortages Task Force has continued to examine the data and further investigate key issues. These findings will be reported Monday, 4 November at ISPE's Annual Meeting in Washington, DC. The Society will also release its 2014 schedule of events related to Drug Shortages in conjunction with the meeting.

About ISPE
ISPE, the International Society for Pharmaceutical Engineering, is the world's largest not-for-profit association serving its Members through leading scientific, technical and regulatory advancement throughout the pharmaceutical lifecycle. The 20,000 Members of ISPE are building solutions in the development and manufacture of safe and effective pharmaceutical and biologic medicines and medical delivery devices in more than 90 countries around the world. Founded in 1980, ISPE has its worldwide headquarters in Tampa, Florida, USA. Visit www.ISPE.org for more information.  To learn more about ISPE's Annual Meeting visit www.ISPE.org/2013annualmeeting

For more information contact:
Danielle Hould
ISPE Membership Marketing Communications Manager
Tel: +1-813-960-2105, ext. 277
Email: dhould@ispe.org
www.ISPE.org  


'/>"/>
SOURCE ISPE
Copyright©2012 PR Newswire.
All rights reserved

Related medicine technology :

1. Dr. Prem Reddy Named Among Most Influential Physician Executives in Nation
2. Bayer Employees Named Rising Stars by Healthcare Businesswomens Association
3. Remedy Informatics Named "Cool Vendor" in Life Sciences by Leading Technology Analyst Firm
4. Dr. Phillip Chan Named Finalist for Ernst & Young Entrepreneur of the Year® 2012 Award in New Jersey
5. Dave Zitnak Of Upsher-Smith Laboratories Named Branded Representative Of The Year By McKesson Corporation
6. StreamVenue Healthcare CEO Named Peoples Choice Winner
7. Masimo CEO Joe Kiani Named Ernst & Young Entrepreneur of the Year
8. Prime Therapeutics Named a Top Workplace by the Minneapolis Star Tribune
9. WellTok Named Colorado Company to Watch for 2012
10. 3 Pediatric Centers that Offer SynCardia Total Artificial Heart Named in Top 10 for "Best Childrens Hospitals"
11. Nonin Medical Named Platinum Partner by Tri-anim Health Services
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:10/2/2017)...  Eli Lilly and Company (NYSE: LLY ... quarter of 2017 on Tuesday, October 24, 2017. Lilly ... with the investment community and media to further detail ... will begin at 9 a.m. Eastern time. Investors, media ... of the conference call through a link that will ...
(Date:9/28/2017)... CHICAGO , Sept. 28, 2017 Hill-Rom ... quarter 2017 earnings conference call and webcast on Friday, ... 8:00 a.m. (EDT) and ending at approximately 8:30 a.m. ... to discussing the company,s 2017 financial performance and guidance ... growth opportunities, initiatives to enhance operational performance, and long-range ...
(Date:9/25/2017)...   Montrium , an industry leader in ... IQPC Trial Master Files & Inspection Readiness Conference ... Clinical Services has selected eTMF Connect ... EastHORN, a leading European contract research organization (CRO), ... to enable greater collaboration with sponsors, improve compliance ...
Breaking Medicine Technology:
(Date:10/13/2017)... ... 2017 , ... PurhealthRX , a leading Health and Nutrition Company, is ... to full spectrum CBD oil will revolutionize the rapidly growing CBD market by reducing ... easily incorporated into liquid products, while reducing costs to end users. , The team ...
(Date:10/13/2017)... Shelton, CT (PRWEB) , ... October 13, 2017 , ... ... and long-term care services, staged a mock evacuation of the facility as part of ... Department, Shelton Fire Department, Echo Hose EMS and Shelton City Emergency Manager, as well ...
(Date:10/13/2017)... ... October 13, 2017 , ... Ellevate Network, the leading network for professional ... action towards gender equality at their inaugural Summit in New York City in June. ... a social audience of over 3 million. To watch the Mobilize Women video, ...
(Date:10/13/2017)... ... ... Talented host, actor Rob Lowe, is introducing a segment ... of "Success Files," which is an award-winning educational program broadcasted on PBS Member ... with passion and integrity. , Sciatica occurs when the sciatic nerve in the ...
(Date:10/13/2017)... ... October 13, 2017 , ... “America On The Brink”: the Christian history ... The Brink” is the creation of published author, William Nowers. Captain Nowers and ... WWII veteran, he spent thirty years in the Navy. Following his career as ...
Breaking Medicine News(10 mins):