Available Resources
A continually growing collection of the most useful regulatory information...
ORGANIZED BY TOPIC and always being updated!
A selection of documents to support protocol development from Phase 1 through Phase 3, and including Master Protocols, and Special Protocol Assessment.
Templates and guidances to write effective and compliant clinical study reports.
A collection of documents for development of FDA and EU meeting preparations, including meeting requests and briefing documents, as well as meeting preparation planning.
A collection of references and tools for effective meetings with European health authorities, both National and EMA regulators.
Resources for ensure DMC processes are developed for clinical trial oversight.
A collection of documents and resources to effectively plan a new IND submission.
Key resources and documents to reference during planning new CTA submissions in both EU and Canada.
Regulatory references to support development which includes use of a companion diagnostic for patient selection.
All of the key resources to plan an application for an expedited program in both the US and EU.
Tools to support strategic planning during drug development, including Target Product Profile (TPP) and guidances related to clinical trial design.
Resources for preparing pediatric development plans in both the US and EU. It is noted that a pediatric plan (or waiver / deferral) must be agreed prior to submission of marketing applications in either region.
Resources related to clinical pharmacology and nonclinical topics.
Resources available for planning financial incentives associated with drug development.
Presentations and Guidances to plan your NDA or BLA.
Helpful guidelines and references for planning a compliant and complete MAA submission via the EU centralized process.
A summary of helpful information related to EU development and potential financial incentives.
The most useful and relevant information to maintain compliance with PVG and safety reporting requirements in the US and EU.
Resources for developing a nonproprietary name (USAN/INN) and proprietary name in US and EU.
What is needed to authorize electronic submissions by a CRO? How to document with FDA that electronic signatures are acceptable? Use these resources to maintain compliance.
Useful guidances and information regarding the development of Cell and Gene Therapies.
Links to memberships, sources for guidance documents and free trainings provided by the health authorities.
Links to general overviews/summaries or the key regulations that are used during drug development.
Information on this currently evolving topic in drug development.
This is an evolving topic with the US FDA and as new resources are identified they will be posted here.
A summary of information on how to conduct complex trials.
A collection of useful reference information for planning PRO use in drug development.