March/April 1997 Selected Contents
Editor's Page
FDA's revised guidance on IVD 510(k)s and the art of communicating with a regulated industry.
Antiidiotypic antibodies as diagnostic reagents
In addition to their therapeutic uses, anti-Ids offer strong potential for diagnostic applications.
Eileen Skaletsky
Coming of electronic age at DCLD
Electronic communications promise swifter handling of IVD product submissions at FDA.
Janice A. Kates, Katie M. Smith, Joseph L. Hackett, Terry McDonald
Effect of formulation on lyophilization, part 2
Expert advice about thermal characteristics, the freeze dryer, secondary drying, and container selection.
Thomas A. Jennings
GMP inspectional consistency: A plan for the future
How FDA and industry can work to improve the consistency of field inspections.
Leif Olsen and Patricia Shrader
Industry News
- Automated Pap screening systems break new ground
- Test developers aim at earlier diagnosis for Alzheimer's
Commentary:
Ethics of IVD use are outside FDA jurisdiction.Glen Paul Freiberg
