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" Act. (b) References in this part to regulatory sections of the Code of Federal Regulations are to Chapter I of Title 21, unless otherwise noted. "
Code of Federal Regulations 21 Parts 800 to 1299 Food and Drugs: Revised as ...
autors: Office of the Federal Register, Office of the Federal Register (U.S.) Staff - 2006 - 796 lapas
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Ethics and Regulation of Clinical Research

Robert J. Levine - 1988 - 484 lapas
...is intended to protect the rights and welfare of human subjects involved in such investigations. (b) References in this part to regulatory sections of...Code of Federal Regulations are to Chapter I of Title 2 1 , unless otherwise noted. § 56.102 Definitions. As used in this part: fa) "Act" means the Federal...
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Code of Federal Regulations: Containing a Codification of Documents of ...

1988 - 590 lapas
...devices, as required by § 807.87. (c) To avoid duplicative listings, a general hospital and personal use device that has two or more types of uses (eg, used both as a diagnostic nisms to grow under suitable conditions indicates the adequacy of sterilization. (2) Classification....
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Code of Federal Regulations: Containing a Codification of Documents of ...

1989 - 464 lapas
...early identification of actions that may significantly affect the quality of the human environment. (e) References in this part to regulatory sections of...to Chapter I of Title 21, unless otherwise noted. § 25.5 Policies. (a) All FDA policies and programs will be planned, developed, and implemented so...
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Validation Compliance Annual: 1995

International Validation Forum - 1995 - 1114 lapas
...Federal Food, Drug, and Cosmetic Act and sections 351 and 354-360F of the Public Health Service Act. (b) References in this part to regulatory sections of...Code of Federal Regulations are to chapter I of title 2 1 , unless otherwise noted. §58.3 Definitions. As used in this part, the following terms shall have...
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Agent GCP and the Bloody Consent Form Guidebook

Daniel Farb, Bruce Gordon - 2005 - 337 lapas
...is intended to protect the rights and welfare of human subjects involved in such investigations. (b) References in this part to regulatory sections of...to Chapter I of Title 21, unless otherwise noted. B 56.102 Definitions. As used in this part: (a) Act means the Federal Food, Drug, and Cosmetic Act,...
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Part 11 and Computer Validation Guidebook

Daniel Farb, Bruce Gordon - 2005 - 329 lapas
...Federal Food, Drug, and Cosmetic Act and sections 351 and 354-360F of the Public Health Service Act. (b) References in this part to regulatory sections of...to Chapter I of Title 21, unless otherwise noted. (43 FR 60013, Dec. 22, 1978, as amended at 52 FR 33779, Sept. 4, 1987) Sec. 58.3 Definitions. As used...
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Pharmaceutical Computer Validation Introduction Guidebook

Daniel Farb, Bruce Gordon - 2005 - 116 lapas
...Federal Food, Drug, and Cosmetic Act and sections 351 and 354-360F of the Public Health Service Act. (b) References in this part to regulatory sections of...to Chapter I of Title 21, unless otherwise noted. (43 FR 60013, Dec. 22, 1978, as amended at 52 FR 33779, Sept. 4, 1987) Sec. 58.3 Definitions. As used...
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Institutional Review Board: Management and Function

Elizabeth A. Bankert, Robert J. Amdur - 2006 - 568 lapas
...Federal Food, Drug and Cosmetic Act and sections 351 and 354-360F of the Public Health Service Act. (b) References in this part to regulatory sections of...to chapter I of title 21, unless otherwise noted. [45 FR 36390, May 30, 1980; 46 FR 8979, Jan. 27, 1981] 5 50.3 Definitions As used in this part: (a)...
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The Gift of Participation: A Guide to Making Informed Decisions about ...

Kenneth Getz - 2007 - 377 lapas
...Federal Food, Drug, and Cosmetic Act and sections 351 and 354-360F of the Public Health Service Act. (b) References in this part to regulatory sections of...to chapter I of title 21, unless otherwise noted. [45 FR 36390, May 30, 1980; 46 FR 8979, Jan. 27, 1981, as amended at 63 FR 26697, May 13, 1998; 64...
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