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In drug development and medical device development [1] the Investigator's Brochure (IB) is a comprehensive document summarizing the body of information about an investigational product ("IP" or "study drug") obtained during a drug trial. The IB is a document of critical importance throughout the drug development process and is updated with new ...
Drugs@FDA Search * Drugs@FDA includes information about drugs, including biological products, approved for human use in the United States (see FAQ), but does not include information about FDA-approved products regulated by the Center for Biologics Evaluation and Research (for example, vaccines, allergenic products, blood and blood products ...
These are lists of investigational drugs: List of investigational analgesics; List of investigational antidepressants; List of investigational antipsychotics; List of investigational anxiolytics; List of investigational attention deficit hyperactivity disorder drugs; List of investigational autism and pervasive developmental disorder drugs ...
In the United States, DMFs are submitted to the Food and Drug Administration (FDA). The Main Objective of the DMF is to support regulatory requirements and to prove the quality, safety and efficacy of the medicinal product for obtaining an Investigational New Drug Application (IND), a New Drug Application (NDA),As an Abbreviated New Drug Application (ANDA), another DMF, or an Export Application.
Template parameters [Edit template data] This template has custom formatting. Parameter Description Type Status; Drug name: drug_name: Name of the drug, medication, or vaccine, including combination drugs. The article title will be used if this is left blank. String: suggested: type: type
An investigational device exemption (IDE) allows an investigational device (i.e. a device that is the subject of a clinical study [1]) to be used in order to collect safety and effectiveness data required to support a premarket approval (PMA) application or a premarket notification [510(k)] submission to Food and Drug Administration (FDA). [2]
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