FDA-speak : a glossary and agency guide by Dean E. Snyder

By Dean E. Snyder

Frequently considered a subdialect of yank "governmentese," FDA-Speak is a language designated to healthcare regulators and people regulated. when you've got any involvement with the USA foodstuff and Drug management, or in the event that they have involvement with you, you want to converse the language. This revised and up-to-date version of FDA-Speak keeps the unique easy-to-use word list layout, yet now comprises greater than thrice the variety of entries within the first variation, defining greater than 2,500 acronyms and technical/regulatory phrases to which the FDA has utilized its personal specific that means. FDA-Speak presents the definitive directory of all the regulatory phrases, words, and acronyms vital to improvement, manufacture, quality controls, advertising and marketing, import/export, and registration of prescription drugs, diagnostic items, scientific units, software program, veterinary items, biologics, nutrients and supplements, and bulk chemical compounds. do not leave out the all-new element of appendices that would advisor you to details you wish at the FDA site.

Appendices contain:
Laws Enforced by way of the FDA; FDA association Charts and make contact with info; FDA box Operations Index and Inspection courses; FDA kinds; FDA assistance files; DSMA employees listing.

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It is applicable to products already licensed. Copyrighted Material 42 Clock Clock Device that generates periodic, accurately spaced signals used for such purposes as timing, regulation of the processor operations, or generation of interrupts. Refer to FDA Glossary of Computerized System and Software Development Terminology. Clone Population of genetically identical cells derived from the multiplication of a single cell. Cloning is the basis of recombinant DNA and monoclonal antibody production.

It may be in one of two states, logic 1 or logic O. It may be thought of as a switch that is either on or off. yti~flldrAf8Jt\edanto computer words of various Block length 25 sizes, such as the byte. Refer to FDA Glossary of Computerized System and Software Development Terminology. Bits per second Measure of the speed of data transfer in a communication system. Refer to FDA Glossary of Computerized System and Software Development Terminology. BL1-LS See Biosafety Level I-Large Scale. BL2-LS See Biosafety Level 2-Large Scale.

Biological containment Measured and calibrated number of microorganisms with high resistance to the mode of sterilization being monitored, placed in or on a carrier and packaged to maintain the integrity of the inoculated carrier and organisms. The organism count is known and is higher than the expected ambient bioburden on the device. Integrating the effects of process conditions can demonstrate through survival or destruction whether or not sterilization conditions were met. Biological Indicator (Bl) Biological product Any virus, therapeutic serum, toxin, antitoxin, vaccine, blood, blood component or derivative, allergenic product, or analogous product applicable to the prevention, treatment, or cure of diseases or injuries of humans.

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