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FDA Internal Standard Operating Procedures for the
This policy establishes the definitions followed by the human research protection program. The defined terms below generally represent either a) terms that are not specifically defined in the regulations, or b) a combination of DHHS and FDA definitions for consistency with both regulations.
fda drug definition

[DOCX File]List of Abbreviations
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The definitions of pasteurization, which are cited in the question, are based on science. These temperatures and times have been adjusted over the years to help insure the destruction of pathogens in milk and milk products. If a firm wanted to use different definitions, the data must be submitted to FDA …
fda definitions list

[DOC File]HHS:PHS:FDA:CFSAN:OFP:DCP:MSB - NCIMS
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For definitions of terms and other information, see Investigational Device Exemptions: Sponsor and Investigator Responsibilities Notice of Device Recall or Disposition The FDA and all reviewing IRBs must be notified of any request made by the sponsor that an investigator return, repair, or otherwise dispose of any unit(s) of an investigational ...
fda glossary of terms

FOOD AND DRUG LAW
Terms and definitions. 4. Principles . 5. General requirements. 5.1 Legal and contractual matters. Legal entity that can be held legally responsible for all its certification activities.
drug substance definition fda

[DOCX File]TERMS AND DEFINITIONS
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Terms and Definitions. Contra-indicated: the risk might outweigh the benefit . Warnings: describes serious adverse reactions and potential safety hazards associated with use of that particular drug . Precautions: any information that addresses any special care that should be taken in using a particular drug
pharmaceutical terms and definitions

Attachment C4: MSAP - CMDCAS - CAN-P-16/1517C ...
Sec. 11.3 Definitions. (a) The definitions and interpretations of terms contained in . section 201 of the act apply to those terms when used in this part. (b) The following definitions of terms also apply to this part: (1) Act means the Federal Food, Drug, and Cosmetic Act (secs. 201-903 (21 U.S.C. 321-393)).
fda terminology

[DOC File]FDA Regulation: 21-CFR-11 Electronic Records and Signatures
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FDA's Multiple Project Assurance (MPA) contains a detailed description of the applicability, principles, FDA policy, FDA staff responsibilities, and FDA’s Institutional Review Board (IRB), the ...
glossary

[DOC File]Glossary and Definitions of Terms Used in GHTF Documents
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An objective is the reason for performing the study in terms of the scientific question to be answered. The primary objective is the main question. This objective generally drives statistical planning for the trial (e.g., calculation of the sample size to provide the appropriate power for statistical testing). ... FDA …
fda glossary and definitions

Definition of Food and Drug Administration
Terms and Definitions . In interpreting this specification, the following words shall have the meanings herein assigned: Bidder: means the natural or juristic person supplying the Goods and/or services as indicated in the contract. Company: means South African Farmers Development Association.
fda drug definition

[DOC File]SOP: Definitions
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Existing Definitions in GHTF documents. Definitions, which appear in GHTF Final Documents, are listed in Appendix A. When writing a new document or modifying an existing one, the relevant Study Group should review the Glossary of Terms in the Appendix and use a definition from the list whenever possible.
fda definitions list

Fda definitions of terms