Reading Room (Electronic Freedom of Information Act)

Products Manufacturers Assistance Health Professionals Assistance Consumer Information Reading Room Approval Information Blood Memos Compliance Program Guides Enforcement Actions FDAMA General / Admin Pubs Guidances Healthcare Letters Information Sheets Meeting Minutes NIDPOE Letters PDUFA Presentations Recalls Rules Safety Information Talk Papers Therapeutic Products Transfer Violative Advert/Promo Warning Letters Meetings & Workshops Research Looking for more exclusive Biotech Information? In addition to our free knowledge base, BiotechWatch provides the following additional services: Premium Database, for in-depth coverage of biotechnology companies in the sector, giving the user the ability to search and sort based on more than twenty parameters. TrialView Database, which offers disease-specific and biotechnology sector-wide clinical trial information. Make your View Count - at BiotechWatch's You Too Can Be An Analyst. Vote on the success of upcoming biotech events. Visit the Biotech Forum, where you can exchange ideas and generate new biotech investments. About Us

The CBER Reading Room provides access to all the documents posted on the CBER website. These documents are ones frequently requested by the public through the Freedom of Information Act. Document Browsing Documents available on the CBER website have been grouped by document type. The document titles can be browsed through the pages listed on the left-hand side under "Reading Room". Additional Documents Available from FDA FDA's Electronic Freedom of Information Reading Room A Handbook for Requesting Information and Records from FDA - Replaces "How to Make a Freedom of Information Request", incorporating information related to the Electronic Freedom of Information Act Center for Devices and Radiological Health Guidance Pertaining to the FDA Modernization Act of 1997 - Guidance for review of devices Looking for more exclusive Biotech Information? In addition to our free knowledge base, BiotechWatch provides the following additional services: Premium Database, for in-depth coverage of biotechnology companies in the sector, giving the user the ability to search and sort based on more than twenty parameters. TrialView Database, which offers disease-specific and biotechnology sector-wide clinical trial information. Make your View Count - at BiotechWatch's You Too Can Be An Analyst. Vote on the success of upcoming biotech events. Visit the Biotech Forum, where you can exchange ideas and generate new biotech investments. Compilation of Laws Enforced by FDA and Related Statutes Compliance Policy Guides Manual - Office of Regulatory Affairs Dockets Management - Official repository for the administrative proceedings and rule-making documents for FDA FDA News and Publications - Press releases, Talk Papers and current issues of other FDA publications Federal Register documents pertaining to FDA - posted by FDA Dockets Management FDA Consumer magazine - Issues from 1995 to the present FDA Forms Distribution Page - Downloadable forms (356h, 1571, 1572, 2253, 2567, 3210, etc.) Additional FDA forms and information on how to obtain Center specific FDA forms can also be found at FDA Forms. FDA Industry Information Portal Looking for more exclusive Biotech Information? In addition to our free knowledge base, BiotechWatch provides the following additional services: Premium Database, for in-depth coverage of biotechnology companies in the sector, giving the user the ability to search and sort based on more than twenty parameters. TrialView Database, which offers disease-specific and biotechnology sector-wide clinical trial information. Make your View Count - at BiotechWatch's You Too Can Be An Analyst. Vote on the success of upcoming biotech events. Visit the Biotech Forum, where you can exchange ideas and generate new biotech investments. Inspection Guides - Office of Regulatory Affairs Related Publications Federal Register - FR Online via GPO Access Code of Federal Regulations - CFR Online via GPO Access International Conference on Harmonisation - ICH Topics and Guidelines MMWR Publications

Updated June 20, 2003