BioPhia Consulting Inc.
CDER Summary February 2017
3/3/2017 9:51:16 AM
CDER Small Business and Industry Education Series:
Best Practices for Communication Between FDA and IND Sponsors During Drug Development
The course describes best practices and procedures for timely, transparent, and effective communications between investigational new drug application (IND) sponsors and FDA at critical junctures in drug development.
Dear Health Care Provider Letters: Improving Communication of Important Safety Information [Guidance for Industry] (PDF - 128KB)
Manual of Policies and Procedures:
6030.9 Good Review Practice: Good Review Management Principles and Practices for Effective IND Development and Review (PDF - 325KB)
Guidance Agenda: New & Revised Draft Guidances CDER is Planning to Publish During Calendar Year 2017 (PDF - 46KB)
Q11 Development and Manufacture of Drug Substances—Questions and Answers (regarding the selection and justification of starting materials. (PDF - 214KB)
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