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FMH College of Medicine & DentistryINSTITUTIONAL REVIEW BOARDProposal Submission Form for IRB Use Only IRB Study #FMS20191. PROJECT IDENTIFICATION Project Title1.2 Principal Investigator (PI) Name

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What is health and biologicalmedical application?

Health and biological medical applications refer to the processes and forms involved in submitting requests for approval or reporting information related to health products, medical devices, biologics, and pharmaceuticals to regulatory agencies.

Who is required to file health and biologicalmedical application?

Manufacturers, importers, and developers of health and biological products, including drugs, medical devices, and biologics, are typically required to file health and biological medical applications.

How to fill out health and biologicalmedical application?

To fill out a health and biological medical application, collect all necessary information regarding the product, including safety and efficacy data, manufacturing details, labeling, and any clinical trial results. Follow the guidelines provided by the regulatory agency to complete the application accurately.

What is the purpose of health and biologicalmedical application?

The purpose of health and biological medical applications is to ensure that health products meet safety, efficacy, and quality standards before they are approved for public use. This process helps protect public health.

What information must be reported on health and biologicalmedical application?

Information reported in a health and biological medical application must typically include product composition, manufacturing processes, clinical trial results, safety data, labeling information, and proposed uses.

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