Investigational Products

Investigational Products (Invest Prod) refers to a preventative (vaccine), a therapeutic (drug or biologic) device, diagnostic, or palliative used in a clinical trial. An investigational product may be an unlicensed or licensed product when used or assembled (formulated or packaged) differently from the approved form, when used for an unapproved indication, or when used to gain further information about an approved use.
Guidance Documents
 |  Product
Comprehensive Guide to Clinical Materials
Guidance Documents
Guidance Documents
Introducing CoP Leader Profiles: Rachel Owen
A New Regulatory Approach to Drive Sustainable Medicines
ISPE Good Practice Guide: Investigational Medicinal Product Reverse Logistics – Good Returns and Reconciliation Practices
Guidance Documents
Brexit: Investigational Medicinal Products, Qualified Person Release & Regulatory Compliance
Model-Informed Drug Development Addresses COVID-19 Challenges
Coronavirus Pandemic: Is Your Supply Chain Continuity Plan Ready
Coronavirus under the microscope
Coronavirus Pandemic: Is Your Supply Chain Continuity Plan Ready

Related Guidance Documents

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Pharmaceutical Engineering Magazine Articles

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A New Regulatory Approach to Drive Sustainable Medicines
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Model-Informed Drug Development Addresses COVID-19 Challenges
Model-Informed Drug Development Addresses COVID-19 Challenges
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