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FDA Lists

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Application Integrity Policy List The names of the firms listed are those that were notified that FDA is deferring substantive scientific review of one or more of the firm's applications and/or is proceeding to withdraw the approved applications.
Disqualified/Restricted/Assurance List for Clinical Investigators This is a list of clinical investigators that have repeatedly or deliberately failed to comply with regulatory requirements for studies or have submitted false information to the study's sponsor.
Enforcement Reports FDA enforcement reports list by year and then by week. Go to FDA Search Page to search enforcement reports by topic or keyword. Be sure to select "Weekly Enforcement Reports from the drop down list.
FDA/ORA Compliance Policy Guides Manual--Medical Devices This list contains titles and hypertext links to all compliance guides involving medical devices.
Import Detention Reports View import detentions country, product, or reason.
Inspection Guides This list contains links to FDA inspection guides for various types of manufacturers and devices.
Import Alerts This database may be searched by country, industry, or import alert number.
 
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