December 16, 2016

New FDA guidance documents available in the Resource Center

By Dr. Isabelle Ragueneau-Majlessi

Two new FDA guidance documents (released in December 2016) have been added to the “Regulatory Guidances” section of the DIDB Resource Center. Please note that you must be signed in to access.

  • Physiologically Based Pharmacokinetic Analyses- Format and Content. Draft Guidance
  • Clinical Pharmacology Section of Labeling for Human Prescription Drug and Biological Products — Content and Format

DIDB Editorial Team