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Date: April 11, 2017, Principal Investigator: Christine Durand, MD Application Number: IRB00089751JHM IRB form A Protocol EXPANDER1 Exploring renal transplants using hepatitis C infected donors for
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Individuals or organizations conducting clinical trials subject to the FDA Amendments Act (FDAAA) regulations
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Any entity with a vested interest in understanding the regulatory framework and requirements of FDAAA
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What is overview of fdaaa and?
Overview of FDAAA stands for Food and Drug Administration Amendments Act and it is a document that provides a summary of the requirements and regulations set forth by the FDA.
Who is required to file overview of fdaaa and?
Manufacturers, distributors, and importers of food and drug products are required to file an overview of FDAAA.
How to fill out overview of fdaaa and?
The overview of FDAAA can be filled out electronically through the FDA's online portal or submitted in paper form via mail or fax.
What is the purpose of overview of fdaaa and?
The purpose of the overview of FDAAA is to ensure compliance with FDA regulations and to provide transparency to consumers about the products being sold in the market.
What information must be reported on overview of fdaaa and?
The overview of FDAAA must include details such as product ingredients, manufacturing processes, labeling information, and any known safety hazards.
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