CRE Homepage About The CRE Advisory Board Newsletter Search Links Representation Comments/Ideas
Data Access
Data Quality
Regulation by Litigation
Regulation by Appropriation
Special Projects
CRE Watch List
OMB Papers
Abstracts and Reviews
Regulatory Review
Voluntary Standards Program
CRE Report Card
Public Docket Preparation
Consumer Response Service
Site Search

Enter keyword(s) to search

®: CRE Regulatory Action of the Week

FDA Seeks Comment on Bioanalytical Method Validation Guidance
The Food and Drug Administration is seeking public comment on its revised draft guidance for industry entitled "Bioanalytical Method Validation." This draft guidance provides recommendations regarding analytical method development and validation for the measurement of drugs and/or metabolites, therapeutic biologics, and biomarkers for sponsors of investigational new drug applications, new drug applications, abbreviated new drug application, and biologics license applications for therapeutic biologics regulated by the Center for Drug Evaluation and Research. This draft guidance may also apply to some studies related to the veterinary drug approval process regulated by the Center for Veterinary Medicine. The FDA requests comments on this draft revised guidance by December 12, 2013.

  • Click here to read Federal Register notice of draft revised guidance