The Federal Drug Administration (FDA) Center for Drug Evaluation and Research (CDER) has issued a list of planned draft and final guidance documents for release in 2012.  There are about 50 such guidances planned.  Below are a few select highlights relevant to the preclinical safety space, with emphasis on the drug development of small molecules.

Electronic Submissions

  • Providing Regulatory Submissions in Electronic Format – General Considerations
  • Providing Regulatory Submissions in Electronic Format – Human Pharmaceutical Product Applications and Related Submissions.  Using the eCTD Specifications
  • Providing Regulatory Submissions in Electronic Format – Study Data
  • Providing Regulatory Submissions in Electronic Format – Standardized Study Data

Procedural

  • Integrated Summary of Safety
  • Investigational New Drug (IND) Applications prepared and submitted by Clinical Sponsor Investigators