2018 is an exciting year for drug development. As FDA Commissioner Scott Gottlieb said in his recent blog post, 2017 saw a number of historic milestones with regard to new innovations. To keep up with the fast-paced, and ever-changing world of drug development, it is critical to consider your clinical pharmacology plan early on in your program.
You will find three essential items that will assist you in planning for a successful clinical pharmacology program in 2018 and beyond.
- Overview of the costs involved in your clinical pharmacology program
- Clinical pharmacology planning timeline & template
- FDA’s Question-Based Review document
Complete the form below to download your 2018 toolkit PDF.