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substantial equivalence
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141	Genetically Engineered Salmon Add to Reading List Source URL: nationalaglawcenter.org Language: English - Date: 2014-05-26 11:33:36 Genetic engineering Emerging technologies Molecular biology Biotechnology Environmental issues Genetically modified food Genetically modified organism Federal Food Drug and Cosmetic Act Substantial equivalence Biology Food and drink Health
142	The New 510(k) Paradigm Alternate Approaches to Demonstrating Substantial Equivalence in Premarket Notifications Add to Reading List Source URL: www.fda.gov Language: English Health Investigational Device Exemption Premarket approval Medical device Federal Food Drug and Cosmetic Act Food and Drug Administration Modernization Act Center for Devices and Radiological Health Design controls Validation Food and Drug Administration Medicine Technology
143	Demonstrating the Substantial Equivalence of a New Tobacco Product: Responses to Frequently Asked Questions Add to Reading List Source URL: www.fda.gov Language: English Ethics Food and Drug Administration Federal Food Drug and Cosmetic Act Family Smoking Prevention and Tobacco Control Act Electronic cigarette Cigarette Center for Tobacco Products Smoking Cigar Tobacco Medicine Pharmacology
144	The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)] Add to Reading List Source URL: www.fda.gov Language: English Technology Premarket approval Federal Food Drug and Cosmetic Act Medical device Center for Devices and Radiological Health Good manufacturing practice Title 21 of the Code of Federal Regulations Investigational Device Exemption Title 21 CFR Part 11 Food and Drug Administration Medicine Health
145	FDAAA Section 913 Supply Chain Security Add to Reading List Source URL: www.fda.gov Language: English Substantial equivalence Food and Drug Administration Tobacco industry Regulation of tobacco by the U.S. Food and Drug Administration Tobacco Health policy Pharmacology
146	Common Issues Identified During FDA’s Scientific Evaluation of SE Reports Summary Brief FDA received 3,126 provisional substantial equivalence (SE) reports before March 23, 2011. SE reports received before March 23, 20 Add to Reading List Source URL: www.fda.gov Language: English Medicine Clinical pharmacology Therapeutics United States Public Health Service Tobacco Electronic cigarette Food and Drug Administration Pharmaceutical sciences Pharmacology
147	510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY TEMPLATE A. 510(k) Number: k063024 B. Purpose for Submission: Add to Reading List Source URL: www.accessdata.fda.gov Language: English - Date: 2008-06-24 16:33:18 Euphoriants Immunologic tests Pharmacology Dopamine agonists Monoamine oxidase inhibitors Immunoassay ELISA Amphetamine Assay Medicine Chemistry Anorectics
148	Product Review Guidances and the Tobacco Product Regulatory Standard Add to Reading List Source URL: www.fda.gov Language: English Pharmaceutical sciences Tobacco Substantial equivalence Federal Food Drug and Cosmetic Act Regulation of tobacco by the U.S. Food and Drug Administration Premarket approval Food and Drug Administration Medicine Health
149	news Call for tighter controls on transgenic foods A senior panel of scientific experts has surprised Canadian regulators — and many Canadians — by calling for far tighter regulation of genetically modified (GM) foo Add to Reading List Source URL: www.nature.com Language: English - Date: 2009-04-23 11:10:59 Environmental issues Knowledge Science and technology in the United Kingdom Food industry Genetically modified food Genetically modified organism Substantial equivalence UK Research Councils Particle Physics and Astronomy Research Council Genetic engineering Biology Science
150	510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY TEMPLATE A. 510(k) Number: k091588 Add to Reading List Source URL: www.accessdata.fda.gov Language: English - Date: 2009-10-05 08:53:58 Medicine Drug test Oxycodone Morphine Methadone MDMA Cocaine Presumptive and confirmatory tests Amphetamine Chemistry Euphoriants Neurochemistry