The ICH has approved a revision to its genotoxicity testing and data interpretation guidelines that it says will improve risk assessment and reduce the number of animals used during preclinical development.
Most Recent Guidances (All Agencies)
- FDA proposes draft guidelines intended to improve the representation of women in medical device clinical studies
- S2 R1
- Good Laboratory Practice for Nonclinical Laboratory Studies
- Codevelopment of Two or More Unmarketed Investigational Drugs for Use in Combination
- Investigational New Drug Applications (INDs)— Determining Whether Human Research Studies Can Be Conducted Without an IND
