| Description |
1 online resource (576 pages) |
| Contents |
Volume I: The â#x80;#x9C;Whyâ#x80;#x9D; of the United States Food and Drug Administration, Landmark Legislation and Court Decisions -- Chapter 1: The Role and Mission of the United States Food and Drug Administration -- A Look Back Unravels the Current Regulatory Environment -- Regulator, Watchdog, and Facilitator -- The FDA Transparency Initiative -- Chapter 2: The Evolution of Food and Drug Law -- Regulation in the 1800sâ#x80;#x94;Food Law, USP, Federal Regulation -- Regulation Throughout the 20th Century -- Chapter 3: Legislative Hallmarks 2000sâ#x80;#x93;Safety and Emerging Trends |
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Regulation in the 21st CenturyEmerging Initiatives -- Chapter 4: Key Regulatory Agencies -- The United States Federal Food and Drug Administration -- Other Notable Federal Agencies -- State, Local and Tribal Governments -- Volume II: Food and Drug Law Administrative Primer -- Chapter 1: Federal Administrative Law Backgrounder -- Legislative Backgrounder -- Administrative Law Backgrounder -- Rulemakingâ#x80;#x94;The Legislative Power -- Investigativeâ#x80;#x94;The Executive Power -- Adjudicationâ#x80;#x94;The Judicial Power -- Limitations of Agency Powers -- Judicial Control |
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Executive ControlsLegislative Controls -- Direct Controls -- Chapter 2: The Federal Register and Code of Federal Regulations -- Federal Registerâ#x80;#x94;Comments, Petitions, Proposed and Final Rules -- Submission of Comments and Petitions -- Proposed Rule: Banned Devicesâ#x80;#x94;Powdered Surgeonâ#x80;#x99;s Gloves -- Code of Federal Regulationsâ#x80;#x94;Rule Codification -- Final Rules under Section 4205 Vending Machines and Restaurant Menus -- Food Labeling |
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Calorie Labeling of Articles of Food in Vending Machines. A final rule was issued December 1, 2014 to assist consumers by requiring the availability of point of purchase nutrition caloric information prior to purchasing the food item. ... Direct Final Rule -- Chapter 3: Freedom of Information Act and Guidance Documents -- Freedom of Information Act -- Guidance Documents -- Volume III: The Food and Drug Administrationâ#x80;#x94;Criminal and Civil Enforcement Strategies -- Chapter 1: Food and Drug Administration Enforcement Mechanisms -- Prohibited Acts and Violations |
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Enforcement TerminologyOther Enforcement Agencies and Private Actions -- Lanham Act Lawsuitâ#x80;#x94;POM Wonderful LLC -- Chapter 2: Inspection, Seizure, Recalls, Warning Letters, Debarment, Detention and Application Integrity Policy -- Inspectionâ#x80;#x94;â#x80;#x9C;482â#x80;#x9D; and â#x80;#x9C;483â#x80;#x9D; and Photographs -- Photographs During an Inspection -- FDA Recall Policy -- Warning Lettersâ#x80;#x94;Traditional and Cyber -- Application Integrity Policy -- Exclusion and Debarment |
| Notes |
""Succinctly stated, individual debarment has serious repercussions and essentially precludes any involvement. Mandatory and Permissive Exclusion under the Social Security Act (SSA) precludes payment from Federal health care programs. A final rule effec ... "" |
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Print version record |
| Form |
Electronic book
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| ISBN |
9780972989176 |
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097298917X |
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