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:4/24/2017)... , April 24, 2017 Solentim, the ... announced the addition of a major new product ... Plate Seeding,). The VIPS has been developed for ... well microplates as part of the process to ... a simple and more reliable solution when compared ...
(Date:4/20/2017)... Research and Markets has announced the addition ... Addressing Production Complexities Through Risk Management and Quality by ... ... Market Prospects: Overcoming Production Complexities Through Risk Management and ... current trends in the global biosimilars market, with a ...
(Date:4/20/2017)... , April 20, 2017  AbbVie (NYSE: ... 99 percent (n=145/146) of chronic hepatitis C virus ... 5 or 6 and compensated cirrhosis (Child-Pugh A) ... (SVR 12 ) with its investigational, pan-genotypic regimen ... rates were seen following 12 weeks of G/P ...
Breaking Medicine Technology:
(Date:4/26/2017)... ... April 26, 2017 , ... Journal of Oral Implantology ... have severe consequences to overall dental health, including complications with speech, eating, and overcompensation ... dental implants to replace lost teeth. As the number of tooth replacements increase, it ...
(Date:4/26/2017)... ... April 26, 2017 , ... ... Hackensack, N.J. has been honored by Enterprising Women magazine as one of its ... world’s top women business owners. Winners have demonstrated that they have fast-growth businesses, ...
(Date:4/26/2017)... (PRWEB) , ... April 26, 2017 , ... RawTrition now ... easy way to get nutrients from SUPERFOODS! , RawTrition is taking nutrients ... the cellular level because the body recognizes its raw form (unlike the synthetically made ...
(Date:4/26/2017)... ... 26, 2017 , ... MYOLYN, a medical technology company dedicated ... received 510(k) clearance from the U.S. Food & Drug Administration (FDA) for two ... devices are stationary cycling systems that use MYOLYN’s patent-pending functional electrical stimulation ...
(Date:4/25/2017)... ... April 25, 2017 , ... ... Newport Beach, California, committed to raising awareness for Duchenne muscular dystrophy, and ... its randomized CAP-1002 (cardiosphere-derived cells) Phase I/II HOPE clinical trial in Duchenne ...
Breaking Medicine News(10 mins):