FavId Shows Promise
for relapsed NHL patients (The Pharm Voice)
In her blog, Gloria Gamat
discusses Favrille's recently announced results of a Phase II trial of its non-Hodgkin's
lymphoma (NHL) drug FavId.
Simplifying Global Compliance
Recommended Products
GMP Inspection Preparation Checklist: A Tool for Internal Auditing
This management report includes more than 650 items organized in three sections covering all aspects of quality manufacturing.
Biological Risk Evaluation and Management for Medical Devices
Report shows how the FDA incorporates the two ISO standards in its medical device development policy, how the EU version of the two standards differs in significant ways and how the EU Medical Device Regulation may require further changes in the European standards.
Editor's Picks
Validation Issues Uncovered at Dannoritzer
Procedures for monitoring and controlling process parameters for a validated process were also found to be inadequate.
Gottlieb Says Agency to Issue Guidelines on Opioid Use for Cancer Pain
Gottlieb said the agency must develop evidence-based guidelines rather than consensus guidelines, which rely too much on “what we currently know.”
