| International Validation Forum - Science - 1995 - 1114 pages
...analogous product, or arsphenamine or its derivatives (or any trivalent organic arsenic compound), applicable to the prevention, treatment, or cure of diseases or injuries of man. Additional interpretation of the statutory language is found in 21 CFR 600.3. Veterinary biologicals... | |
| Lisa A Basara, Michael E Montagne - Science - 1994 - 296 pages
...toxin, antitoxin, vaccine, blood, blood component or derivative, allergenic product, or similar product applicable to the prevention, treatment, or cure of diseases or injuries of humans. Specific biologies include albumin and packed red blood cells-two products that are used for... | |
| Anthony Atala, David J. Mooney - Science - 1997 - 276 pages
...analogous product, or arsphenamine or its derivatives (or any other trivalent organic arsenic compound), applicable to the prevention, treatment, or cure of diseases or injuries of man." Products considered to be "biological products" under the PHS Act are also considered "drugs" or "devices"... | |
| Gregory Higby, Elaine Condouris Stroud - Chemotherapy - 1997 - 328 pages
...other laws under the PHS 's jurisdiction, a biologic product was, by definition, a serum, toxin, etc. "applicable to the prevention, treatment or cure of diseases or injuries of man;" see 12 Fed. Reg. 6218, 16 September 1947. 24. "Mixed Vaccines," Journal of the American Medical Association... | |
| Hansjörg Hauser, Roland Wagner - Science - 1997 - 520 pages
..."... "Biological product" means any virus, therapeutic serum, toxin, antitoxin, or analogous product applicable to the prevention, treatment or cure of diseases or injuries of man: . . . ". However the regulation affairs between drugs (CFR 21 subchapter C and D) are very similar... | |
| David H. Sierra, Renato Saltz - Technology & Engineering - 1998 - 276 pages
...antitoxin, vaccine, blood, blood component or derivative, allergenic product, or analogous product . . . applicable to the prevention, treatment, or cure of diseases or injuries of man . . ." [2]. Although there are similarities between the definitions of drugs and of biologics, there... | |
| Alan Rudolph - Medical - 1997 - 512 pages
...antitoxin, vaccine, blood, blood component or derivative, allergenic product, or analogous product . . . applicable to the prevention, treatment or cure of diseases or injuries of man." While there are similarities between drugs and biologics, there are important differences. Drugs have... | |
| Barry Leonard - 1999 - 115 pages
...any other trivalent organic arsenic compound), except materials to be used in research experiments, applicable to the prevention, treatment, or cure of diseases or injuries of man is prohibited unless these products have been propagated or prepared at any establishment holding an... | |
| U.S. Customs Service - Customs administration - 216 pages
...analogous product, or arsphenamine or its derivatives (or any other trivalent organic arsenic compound), applicable to the prevention, treatment, or cure of diseases or injuries of man is prohibited unless such virus, serum, toxin, antitoxin, or other product has been manufactured at... | |
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