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Individual Patient Expanded Access Applications: Form FDA 3926 Guidance for Industry. S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research
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Who needs form FDA access?

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Individuals or entities seeking access to certain resources, information, or services provided by the U.S. Food and Drug Administration (FDA).
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Regulatory or industry professionals requiring access to FDA databases, guidelines, or other relevant resources for compliance or decision-making purposes.
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Form FDA Access is a document used by individuals or organizations to request access to information collected by the FDA that is not typically publicly available.
Any individual or organization that seeks access to specific FDA records, data or information can file Form FDA Access.
To fill out Form FDA Access, provide the requested information accurately, including details about the specific records or information desired, and submit it according to the instructions provided by the FDA.
The purpose of Form FDA Access is to facilitate the process by which individuals and organizations can request and obtain information from the FDA regarding public health and safety.
The information that must be reported on Form FDA Access includes the applicant's details, description of the specific records requested, the rationale for the request, and any relevant deadlines.
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