The FDA has published an updated Guidance Agenda – new and revised draft guidances CDER is planning to publish during calendar year 2012. Guidances of particular interest to nonclinical pharmaceutical toxicologists may include:
Pharmacology/Toxicology
• Endocrine Disruption Potential of Drugs: Non Clinical Evaluation
Procedural
• Integrated Summary of Safety
Biopharmaceutics
• Food-Effect Bioavailability and Fed Bioequivalence Studies—Bioavailability and Bioequivalence Studies for Orally Administered Drug Products Submitted in New Drug Applications General Consideration
Electronic Submissions
• Providing Regulatory Submissions in Electronic Format – General Considerations
• Providing Regulatory Submissions in Electronic Format – Study Data
• Providing Regulatory Submissions in Electronic Format – Standardized Study Data