Documents

Electronic copies of most guidances, guidelines and other documents issued by FDA are available at the Agency's Web site within a very short time after their publication. For this reason, The Regulatory Forum has assembled a series of links below to the Guidance Document pages of various FDA Divisions. All FDA pages are searchable using the FDA Web site's search engine.

Many of the files at FDA's Web site, the GPO Access site, and other locations are presented as *.pdf files, a proprietary file format developed by Adobe. If you have not already done so, download a free copy of the Acrobat Reader to view *.pdf files. Acrobat and the Acrobat logo are trademarks of Adobe Systems Incorporated.

Many files are also offered in *.ppt format (PowerPoint files), which must be viewed with either the PowerPoint application or PowerPoint Viewer. If you have not already done so, download a free copy of the PowerPoint Viewer to view *.ppt files. PowerPoint and PowerPoint Viewer are trademarks of Microsoft Corporation.

Center for Drug Evaluation and Research (FDA CDER)

• FDA CDER Guidance Document Home Page
• FDA Federal Register Documents
• FDA CDER Regulatory Guidance Home Page. Includes links to CDER's FDAMA page, Standards Manual, Y2K Information, Human Drug Current Good Manufacturing Notes, Title 21 of the CFR, and other documents. Usually also includes links to new proposed and final rules.

Center for Biologics Evaluation and Research (FDA CBER)

• FDA CBER Guidance Document Home Page
• FDA CBER Points to Consider Home Page
• FDA CBER Proposed and Final Rules Home Page

Center for Devices and Radiological Health (FDA CDRH)

• Topical Index of All CDRH On-line Documents
• CDRH New Items Home Page. Links to new draft and final guidances, new proposed and final rules, meeting announcements, product approvals and clearances, committee meetings, and other documents -- typically spans a period of approximately the last 30 days.
• Recent CDRH Federal Register Notices
• Link to sign up for Automatic Delivery of CDRH Web Site Updates

Other Regulatory Links

• Link to FDA's MedWatch Forms for Medical Products Reporting
• FDA's Year 2000 Web Site
• Link to FDA'S Forms Distribution Page
• Link to Small Business Guide to FDA

• Federal Register Online via GPO Access (1995 to Current)

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