At Nuventra we strive to help our clients and readers navigate the drug development process with ease. Our toolkits include articles, guides, checklists, cheat-sheets, relevant FDA guidances, and more to help make your drug development process a little easier.
Follow the links below to have any of our toolkits emailed directly to you.
Clinical Pharmacology Planning Toolkit
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. In this Clinical Pharmacology Planning Toolkit, you will find three essential items that will assist you in planning for a successful clinical pharmacology program in 2019 and beyond.
- Overview of the costs involved in your clinical pharmacology program
- Clinical pharmacology planning timeline & template
- FDA’s Question-Based Review document
Toolkit for Communicating with FDA
Clear communication with the FDA can greatly increase the chances of getting your drug approved. In this toolkit, you will find essential resources to improve your communication with the FDA. You will also benefit from first-hand experience and advice from Nuventra consultants Gene Williams and Brian Furmanski, who spent a combined 23 years as Clinical Pharmacology Reviewers at the FDA. The five sections include:
- Part 1: Communicating Effectively with the FDA; Roles & Responsibilities / Dos & Don’ts
- Part 2: Questions & Answers with Former FDA Reviewers
- Part 3: Cheat Sheet: Meeting Types and Timing
- Part 4: Relevant Guidances from the FDA
- Part 5: Meet Nuventra’s Former FDA Reviewers