Suchergebnisse

Digest of relevant court opinions handed down since 1933. ; Part of a project to supplement: United States. Dept. of Agriculture. Office of the General Counsel. Decisions of courts in cases under the Federal Food and Drugs Act. ; Mode of access: Internet.

FDA is currently developing a policy regarding application of the Food, Drug and Cosmetic Act in the medical software marketplace. It should be available for review in draft form in summer or early fall 1986. This paper reviews the Agency's device regulation program and its implications for any medical software products deemed to be medical devices under that policy. It is anticipated that implementation will proceed smoothly, without undue delay or expense to industry or government.

"Public Law 102-282." ; "106 Stat. 149." ; "May 13, 1992, (H.R. 2454)." ; Shipping list no.: 92-333-P. ; Caption title. ; Mode of access: Internet.

Item 1043-A, 1043-B (microfiche). ; Shipping list no.: 86-131-P. ; Distributed to some depository libraries in microfiche. ; Pt. 2: Addendum. ; Includes bibliographical references. ; Mode of access: Internet.

"July 29, 2009." ; Shipping list no.: 2009-0420-P. ; Caption title. ; Mode of access: Internet.

Shipping list no.: 96-0240-P. ; Distributed to some depository libraries in microfiche. ; Includes bibliographical references. ; Mode of access: Internet.

This report provides a brief policy background narrative and an overview of provisions for each title of the Food and Drug Administration Safety and Innovation Act (FDASIA), P.L. 112-144. The legislation amends the Federal Food, Drug, and Cosmetic Act (FFDCA) to expand the authority of the Food and Drug Administration (FDA) in performing its human drug, biological product, and medical device responsibilities.

1 History of Food Laws in the United States -- 2 The Setting for Food Regulatory Programs -- 3 The Legal System in the United States Government -- 4 Establishing a Legal Basis for Food Regulatory Programs -- 5 The Enactment of Federal Legislation -- 6 Publication, Documentation and Codification of Federal Legislation -- 7 Regulations -- 8 Publication of Federal Regulations -- 9 How to Use the Code of Federal Regulations and the Federal Register -- 10 Regulatory Agencies -- 11 Food Standards -- 12 Product Liability -- 13 Current Federal Food Laws -- 14 Selected Laws Relating to Operation of the Federal Government -- 15 United States Grain Standards Act of 1976 -- 16 Federal Insecticide, Fungicide, and Rodenticide Act -- 17 United States Warehouse Act -- 18 Perishable Agricultural Commodities Act, 1930 -- 19 Agricultural Marketing Act of 1946 -- 20 Animal Welfare Act -- 21 Federal Trade Commission Act -- 22 Fair Packaging and Labeling Act -- 23 Tea Importation Act -- 24 Filled Milk Act -- 25 Import Milk Act -- 26 Butter Act -- 27 Dry Milk Solids Act -- 28 Federal Meat Inspection Act -- 29 Poultry Products Inspection Act -- 30 Egg Products Inspection Act -- 31 Federal Alcohol Administration Act and the Internal Revenue Code—Alcohol Excise Taxes -- 32 Occupational Safety and Health Act of 1970 -- 33 Clean Water Act of 1977 -- 34 Public Health Service Act: Grade A Pasteurized Milk Ordinance; Grade A Condensed and Dry Milk Products Sanitation Ordinance; Safe Drinking Water Act -- 35 Environmental Law: National Environmental Policy Act of 1969; Environmental Quality Improvement Act of 1970; Resource Conservation and Recovery Act of 1976 Clean Air Act Noise Control Act of 1972 -- 36 Federal Food, Drug, and Cosmetic Act: The Extent of Its Intent -- 37 Federal Food, Drug, and Cosmetic Act—Sections 301, 321, 321a, 321b and 321c: Short Title and Definitions -- 38 Federal Food, Drug, and Cosmetic Act—Sections 331–337: Prohibited Acts and Penalties -- 39 Federal Food, Drug, and Cosmetic Act—Section 341: Definitions and Standards for Foods -- 40 Federal Food, Drug, and Cosmetic Act—Section 342: Adulterated Food -- 41 Federal Food, Drug, and Cosmetic Act—Section 343: Misbranded Food -- 42 Federal Food, Drug, and Cosmetic Act—Sections 344 and 345: Emergency Permit Control; Regulations Making Exemptions -- 43 Federal Food, Drug, and Cosmetic Act—Section 346: Tolerances for Poisonous and Deleterious Substances in Food -- 44 Federal Food, Drug, and Cosmetic Act—Sections 346a and 346b: Tolerances for Pesticide Chemicals in or on Raw Agricultural Commodities; Authorization of Appropriations -- 45 Federal Food, Drug, and Cosmetic Act—Sections 347, 347a and 347b: Oleomargarine -- 46 Federal Food, Drug, and Cosmetic Act—Section 348: Food Additives -- 47 Federal Food, Drug, and Cosmetic Act—Sections 349, 350 and 350a: Bottled Drinking Water Standards; Vitamins and Minerals; Infant Formulas -- 48 Federal Food, Drug, and Cosmetic Act—Sections 371–375: Regulations, Hearings and Other Administrative Provisions; Seafood Inspection -- 49 Federal Food, Drug, and Cosmetic Act—Section 376: Listing and Certification of Color Additives for Foods, Drugs, Devices and Cosmetics -- 50 Federal Food, Drug, and Cosmetic Act—Sections 377–379: Advertising of Foods; Confidential Information -- 51 Federal Food, Drug, and Cosmetic Act—Sections 381, 391 and 392: Imports and Exports; Miscellaneous -- Appendix A—Action Levels for Poisonous or Deleterious Substances -- Appendix B—Defect Action Levels -- Appendix C—List of General Food Categories -- Laws Cited.