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DOL - 29 CFR PART 1987 - PROCEDURES FOR HANDLING RETALIATION COMPLAINTS UNDER SECTION 402 OF THE FDA FOOD SAFETY MODERNIZATION ACT Organization: DOL
Date: 2014-07-01
Description: (a) This part sets forth the procedures for, and interpretations of, section 402 of the FDA Food Safety Modernization Act (FSMA), Public Law 111–353, 124 Stat. 3885, which was signed into law on January 4, 2011. Section 402 of the FDA Food Safety Modernization Act amended the Federal Food, Drug, and Cosmetic Act (FD&C), 21 U.S.C. 301 et seq., by adding new section 1012.
DOL - 29 CFR PART 1987 - PROCEDURES FOR HANDLING RETALIATION COMPLAINTS UNDER SECTION 402 OF THE FDA FOOD SAFETY MODERNIZATION ACT Organization: DOL
Date: 2015-07-01
Description: (a) This part sets forth the procedures for, and interpretations of, section 402 of the FDA Food Safety Modernization Act (FSMA), Public Law 111–353, 124 Stat. 3885, which was signed into law on January 4, 2011. Section 402 of the FDA Food Safety Modernization Act amended the Federal Food, Drug, and Cosmetic Act (FD&C), 21 U.S.C. 301 et seq., by adding new section 1012.
DOL - 29 CFR PART 1987 - PROCEDURES FOR HANDLING RETALIATION COMPLAINTS UNDER SECTION 402 OF THE FDA FOOD SAFETY MODERNIZATION ACT Organization: DOL
Date: 2016-07-01
Description: (a) This part sets forth the procedures for, and interpretations of, section 402 of the FDA Food Safety Modernization Act (FSMA), Public Law 111–353, 124 Stat. 3885, which was signed into law on January 4, 2011. Section 402 of the FDA Food Safety Modernization Act amended the Federal Food, Drug, and Cosmetic Act (FD&C), 21 U.S.C. 301 et seq., by adding new section 1012.
NPFC - DI-TCSP-82040 - RESEARCH AND DEVELOPMENT OF MEDICAL PRODUCTS REGULATED BY THE U.S. FOOD AND DRUG ADMINISTRATION (FDA) Organization: NPFC
Date: 2016-05-03
Description: Use/relationship: This Data Item Description (DID) is published by the U.S Army Medical Research & Materiel Command (USAMRMC) to facilitate the acquisition of technical data to support the research and development of drugs, biologics, medical devices, or some component thereof regulated by the U.S. Food and Drug Administration (FDA). This DID contains the format, content, and intended use information for the data deliverable resulting from the work task described in the solicitation.
DODD 6200.02 02/27/08 - APPLICATION OF FOOD AND DRUG ADMINISTRATION (FDA) RULES TO DEPARTMENT OF DEFENSE FORCE HEALTH PROTECTION PROGRAMS Organization: DODD
Date: 2008-02-27
Description: (Reference (e)); Executive Order 13139 (Reference (f)); and Parts 50, 56, 312, Subpart I of Part 314, Subpart G of Part 601 of title 21, Code of Federal Regulations (Reference (g)), for application of FDA rules to force health protection programs of the Department of Defense involving medical products required to be used under an Emergency Use Authorization (EUA) or an investigational new drug (IND) application.
CRC - FDA REGULATORY AFFAIRS - FDA REGULATORY AFFAIRS - THIRD EDITION Organization: CRC
Date: 2014-02-28
Description: Preface This book is a roadmap to the U.S. Food and Drug Administration (FDA) and drug, biologic, and medical device development.
ASQ - STATS PROC CNTRL FDA-REG IND - STATISTICAL PROCESS CONTROL FOR THE FDA-REGULATED INDUSTRY Organization: ASQ
Date: 2013-01-01
Description: The focus of this book is to understand and apply the different SPC tools in a company regulated by the Food and Drug Administration (FDA): those that manufacture pharmaceutical products, biologics, medical devices, food, cosmetics, and so on.
ASQ - QUAL RISK MGT FDA-REG IND - QUALITY RISK MANAGEMENT IN THE FDA-REGULATED INDUSTRY Organization: ASQ
Date: 2012-01-01
Description: Risk management principles are effectively utilized in many areas of business and government, including finance, insurance, occupational safety, and public health, and by agencies regulating these industries. The U.S. Food and Drug Administration (FDA) and its worldwide counterparts are responsible for protecting public health by ensuring the safety and effectiveness of the drugs and medical devices.
HHS - 21 CFR PART 314 - APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG Organization: HHS
Date: 2014-04-01
Description: (b) This part does not apply to drug products subject to licensing by FDA under the Public Health Service Act (58 Stat. 632 as amended (42 U.S.C. 201 et seq.)) and subchapter F of chapter I of title 21 of the Code of Federal Regulations.
HHS - 21 CFR PART 314 - APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG Organization: HHS
Date: 2015-04-01
Description: (b) This part does not apply to drug products subject to licensing by FDA under the Public Health Service Act (58 Stat. 632 as amended (42 U.S.C. 201 et seq.
HHS - 21 CFR PART 314 - APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG Organization: HHS
Date: 2016-04-01
Description: (b) This part does not apply to drug products subject to licensing by FDA under the Public Health Service Act (58 Stat. 632 as amended (42 U.S.C. 201 et seq.)) and subchapter F of chapter I of title 21 of the Code of Federal Regulations.
ASTM D4754 - STANDARD TEST METHOD FOR TWO-SIDED LIQUID EXTRACTION OF PLASTIC MATERIALS USING FDA MIGRATION CELL Organization: ASTM
Date: 2011-12-01
Description: Because it employs two-sided extraction, this test method may not be suitable for multi-layered plastics intended for single-sided food contact use. The size of the FDA migration cell as described may preclude its use in determining total nonvolatile extractives in some cases.
ARMY - AR 40-660 - DOD HAZARDOUS FOOD AND NONPRESCRIPTION DRUG RECALL SYSTEM Organization: ARMY
Date: 2003-11-14
Description: To prescribe policy guidance and assign responsibilities within the DoD to be followed when recalls of hazardous, tampered or suspected tampering of foods or nonprescription drugs, nonprescription medical devices, and health and beauty aids (hereinafter collectively called hazardous food and nonprescription drugs) are issued by the Food and Drug Administration (FDA), U.S Department of Agriculture (USDA), U.S.
WILEY - PLASTIC PACKAGING: INTERA - PLASTIC PACKAGING: INTERACTIONS WITH FOOD AND PHARMACEUTICALS 2ND COMPLETELY REVISED EDITION COMPLETE DOCUMENT Organization: WILEY
Date: 2008-01-01
Description: Materials characteristics, additives and their effects, mass transport phenomena such as diffusion, migration, and permeation that lead to interactions between the environment, the packaging material and the packed goods, quality assurance, and recent regulatory requirements from FDA and European Commission are covered in detail with ample data.
ARMY - AR 40-7 - USE OF U.S. FOOD AND DRUG ADMINISTRATION-REGULATED INVESTIGATIONAL PRODUCTS IN HUMANS INCLUDING SCHEDULE I CONTROLLED SUBSTANCES Organization: ARMY
Date: 2009-10-19
Description: Purpose This regulation prescribes Department of the Army (DA) policies, procedures, and responsibilities for the use of U.S. Food and Drug Administration (FDA)-regulated investigational products, the use of FDA-approved drugs for unapproved indications in humans, and the use of U.S.
AOAC MASN - MICROBIOLOGICAL ANALYSIS OF SELECTED NUTRIENTS - TO PURCHASE CALL 1-800-854-7179 USA/CANADA OR 303-397-7956 WORLDWIDE Organization: AOAC
Date: 1996-01-01
Description: Gerald Angyal, Editor This manual provides analysts with standard operating procedures describing methods used by the U. S. Food and Drug Administration (FDA) in analysis for the following: the water-soluble vitamins biotin, folic acid, niacin, pantothenic acid, riboflavin, thiamin, pyridoxine, and vitamin B12; several other nutrients including choline and tryptophan; and panthenol, an ingredient in many cosmetics.
HHS - 21 CFR PART 806 - MEDICAL DEVICES; REPORTS OF CORRECTIONS AND REMOVALS Organization: HHS
Date: 2014-04-01
Description: (a) This part implements the provisions of section 519(g) of the Federal Food, Drug, and Cosmetic Act (the act) requiring device manufacturers and importers to report promptly to the Food and Drug Administration (FDA) certain actions concerning device corrections and removals, and to maintain records of all corrections and removals regardless of whether such corrections and removals are required to be reported to FDA.
HHS - 21 CFR PART 806 - MEDICAL DEVICES; REPORTS OF CORRECTIONS AND REMOVALS Organization: HHS
Date: 2015-04-01
Description: (a) This part implements the provisions of section 519(g) of the Federal Food, Drug, and Cosmetic Act (the act) requiring device manufacturers and importers to report promptly to the Food and Drug Administration (FDA) certain actions concerning device corrections and removals, and to maintain records of all corrections and removals regardless of whether such corrections and removals are required to be reported to FDA.
HHS - 21 CFR PART 806 - MEDICAL DEVICES; REPORTS OF CORRECTIONS AND REMOVALS Organization: HHS
Date: 2016-04-01
Description: (a) This part implements the provisions of section 519(g) of the Federal Food, Drug, and Cosmetic Act (the act) requiring device manufacturers and importers to report promptly to the Food and Drug Administration (FDA) certain actions concerning device corrections and removals, and to maintain records of all corrections and removals regardless of whether such corrections and removals are required to be reported to FDA.
HHS - 21 CFR PART 1150 - USER FEES Organization: HHS
Date: 2015-04-01
Description: All domestic manufacturers and importers of tobacco products are required to pay to FDA their percentage share of the total assessment for a fiscal year.

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