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FDA Home Page | Federal-State | Import Program | Compliance | Inspection | Science | ORA Search  | ||
Small Business Guide to FDA
|
| Web Site and Web Site Address | Description |
|---|---|
| CBER - Biologics Standard Operating Policy
and Procedures http://www.fda.gov/cber/regsopp/8403.htm |
license forms, instructions, guidance |
| CBER - Center for Biologics Evaluation
and Research http://www.fda.gov/cber/index.html |
blood, biologic products, tissue, in-vitro diagnostics |
| CBER - Site Map http://www.fda.gov/cber/sitemap.htm |
links to blood, tissue, and biologics information |
| CDER - ANDA Application Process http://www.fda.gov/cder/regulatory/applications/ANDA.htm |
forms for generic drug submissions, instructions, guidance |
| CDER - Center for Drug Evaluation & Research http://www.fda.gov/cder/ |
prescription human drugs, over-the-counter drugs, medical gases |
| CDER – Drug Registration / Listing http://www.fda.gov/cder/drls/default.htm |
facility registration and drug listing forms, instructions, guidance |
| CDER – IND Application Process http://www.fda.gov/cder/regulatory/applications/ind_page_1.htm |
investigational drug forms, instructions, guidance |
| CDER – NDA Application Process http://www.fda.gov/cder/regulatory/applications/NDA.htm |
forms for new drug submissions, instructions, guidance |
| CDER – Small Business Assistance http://www.fda.gov/cder/about/smallbiz/default.htm |
assistance for new and small drug businesses |
| CDRH – Center for Devices & Radiological
Health http://www.fda.gov/cdrh/index.html |
human and animal devices, in-vitro diagnostics, radiologicals, lasers |
| CDRH – Device Advice http://www.fda.gov/cdrh/devadvice/ |
device advice, search device databases; 510k / PMA help |
| CDRH – Device Registration / Listing http://www.fda.gov/cdrh/devadvice/341.html |
forms for facility registration and device listings, instructions, guidance |
| CDRH / Industry Assistance http://www.fda.gov/cdrh/industry-asst.html |
assistance for small device businesses |
| CFSAN – Center for Food Safety & Applied
Nutrition http://vm.cfsan.fda.gov/list.html |
food [except red meat and poultry], dietary supplements, food additives, cosmetics, dinnerware |
| CFSAN – LACF / Acidified Food Registration
/ Process Filing http://www.cfsan.fda.gov/~comm/lacf-s1.html |
forms for facility registration and filing a cooking process [acidified and low acid canned foods only], instructions, and guidance |
| CFSAN – Starting a Food Business http://www.cfsan.fda.gov/~comm/foodbiz.html |
information, assistance for new food businesses |
| Compilation of Laws Enforced by Food & Drug
Administration http://www.fda.gov/opacom/laws/ |
access all FDA regulations |
| CVM - Center for Veterinary Medicine http://www.fda.gov/cvm/default.html |
animal drugs, animal feed, pet products |
| CVM - FAQ's http://www.fda.gov/cvm/faqs/faqs.html |
Frequently Asked Questions [and Answers] about veterinary regulations |
| CVM - NADA / ANADA Application Process http://www.fda.gov/cvm/index/other/nadaappr.htm |
forms for new animal drug submissions, instructions, guidance |
| FDA - Citizen Petitions http://www.fda.gov/opacom/morechoices/smallbusiness/citizpet.html |
petition requests to add, remove, or change agency regulations |
| FDA - Ombudsman http://www.fda.gov/oc/ombudsman/homepage.htm |
mediation, resolution of disputes with FDA and help for industry |
| FDA - Public Docket of Proposed Regulations http://www.fda.gov/ohrms/dockets/ |
comment on proposed regulations, view pending regulations |
| FDA - Public Hearings http://www.fda.gov/opacom/morechoices/smallbusiness/pubhear.html |
how to participate in FDA's rulemaking process |
| FDA - Recalls http://www.fda.gov/ora/compliance_ref/recalls/recallpg.html |
product recall information, regulations, procedures |
| FDA FOI - Handbook for Requesting Information and Records http://www.fda.gov/opacom/backgrounders/foiahand.html |
how to submit requests under the Freedom of Information Act |
| FDA Home Page http://www.fda.gov/ |
starting point for all FDA web sites |
| FDA Modernization Act http://www.fda.gov/opacom/7modact.html |
changes to FDA regulations since 1997 |
| Information for FDA-Regulated Industry http://www.fda.gov/oc/industry/default.htm |
FDA-regulated industry web sites |
| State Health Agencies http://www.fda.gov/oca/sthealth.htm |
links to state agencies |
| US Government - Superintendent of Documents http://www.fda.gov/opacom/morechoices/smallbusiness/supdoc.html |
access to all government publications |
| US Government CFR's Online http://www.access.gpo.gov/nara/cfr/cfr-table-search.html |
access to all government regulations that are online |
| USDA - Home Web site http://www.usda.gov/ |
red meat, poultry regulations, information |