FDA News and Analysis

• Regulation of Combination Products by the FDA
  
• Combination products, i.e., those containing any combination of a drug, device, or biological, constitute a growing category of innovative medical products. Examples include a drug with an implantable delivery device, drug-eluting cardiovascular ste ... more »
  

Feature Articles

• Growth of Virginia's Life Science Clusters
  
• Strategically located near Federal institutions (like the National Institutes of Health) and regulatory agencies (like the Food and Drug Administration), Virginia is an ideal place for life science companies. According to the Virginia Biotechnology ... more »
  

• Medicinal Chemistry Equals New Leads
  
• Susan Aldridge, Ph.D.
• Innovative approaches to medicinal chemistry in a number of important therapeutic areas were under discussion at Scientific Update's conference "MedChem Europe: Molecules that Matter" held in Berlin recently. Smarter medicinal chemistr ... more »
  

• Signal Pathways Making Inroads in Discovery
  
• Signal pathways control a vast range of cellular events and keep cells operating cohesively. Extracellular changes are communicated inside cells via cell-surface receptors, like tyrosine kinase, G-protein coupled receptors, and ion-channel receptors ... more »
  

• Moving Toward System-Wide Software Suites
  
• Gail Dutton
• Electronic clinical trials are moving from standalone, point solutions toward software suites, similar to the way office applications migrated in the 1980s. Eventually, investigators will have a seamless, system-wide software suite on a single platf ... more »
  

• Preparation of Clinical Trials Materials
  
• Contract preparation of clinical trial materials has been a growing business since the mid 1980s in Europe and the 1990s in the U.S., explains Gary Sutterlin, director of clinical trial project management at Cardinal Health (Philadelphia). Prior to ... more »