This revision of the document issued in 2005 updates the FDA-recognized standards and clarifies our recommendations for microbial ingress testing.
Guidance for Industry and FDA Review Staff - Intravascular Administration Sets Premarket Notification Submissions [510(k)]
PMA Final Decisions for August 2008
These are Premarket Approvals (PMA), Product Development Protocols (PDP), Supplement and Notice Decisions for May 2008.
Researchers turn plant cells into medical factories
VTT Technical Research Centre of Finland will coordinate the large EU research project called SmartCell. The four-year project focuses on developing methods for production of valuable pharmaceutical compounds using plant cells as a production host in an effective and controlled manner.
Drug Index Safety System - New Drug Labeling System Eliminates Medication Error At Patient Bedside
The Drug Index Safety System, developed by Dr. Tracy and Mr. Brent Dallman, is a groundbreaking system that enhances electronic patient record keeping systems, especially at the bedside. Patient information systems, barcoding, electronic medical records, and item level tracking have been high priorities in health care for the last several years to address and reduce medication errors.
Covidien Launches TussiCaps(R) Extended-Release Capsules To Relieve Cold-Related Cough
Covidien (NYSE: COV, BSX: COV), a leading global provider of healthcare products, announced the U.S. availability of TussiCaps® (hydrocodone polistirex/chlorpheniramine polistirex) extended-release capsules, the first and only hydrocodone antitussive oral capsule to provide powerful cough suppression for up to 12 hours.
Clinical Trials: The Features And Promises Of The Brazilian Market
Frost & Sullivan will host a live briefing on Tuesday, September 23, at 3:00 pm EDT to provide industry participants an overview of a recently published study focusing on Clinical Trials Markets in Brazil. Over the years, Brazil has increasingly raised its attractiveness for pharmaceutical clinical trials and outsourcing due to cost advantages, considerable patient pool and quality resources.
New IRI Research Reveals Resilience Of Healthcare Industry In The Transforming Economy
In an economy undergoing dramatic transformation resulting from unprecedented petroleum and commodity price increases, healthcare is delivering solid growth to retailers, relative to the rest of the store, but manufacturers are contending with a sharp increase in private label purchases, notes new research announced today by Information Resources, Inc. (IRI).
Diabetics: Attitudes And Behaviors In The United States 2008 - Report By Research And Markets
Research and Markets has announced the addition of the “Diabetics: Attitudes and Behaviors in the United States 2008″ report to their offering. Diabetes is a highly complex disease that entails a range of screening methods, treatment, monitoring, and management. Comprised of pre-diabetes, Type 1 (an autoimmune disease) and Type 2 (a metabolic disorder), diabetes affects 23.6 million people in the U.S.
Expert Says Eshoo-Barton Bill Stifles Drug Innovation, USA
Pending legislative proposals in Congress to create a follow-on biologics (FOBs) pathway risk overextending monopoly protection and undermining innovation, according to a comprehensive analysis released today by Boston University Economics Professor Laurence J. Kotlikoff and commissioned by Teva Pharmaceuticals USA. Dr.
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