Page 1 of 8. Connotation and Denotation. Connotation and Denotation. Connotation and Denotation are two principal methods of describing the meanings of. words. Connotation refers to the wide array of positive and negative associations that. most words naturally carry with them, whereas denotation is the precise, literal definition. of a word that might be found in a dictionary.
Medical Definition of orphan drug. : a drug that is not developed or marketed because its extremely limited use (as in the treatment of a rare disease) makes it unprofitable.
This status is referred to as orphan designation (or sometimes âorphan statusâ). For a drug to qualify for orphan designation both the drug and the disease or condition must meet certain criteria specified in the ODA and FDAâs implementing regulations at 21 CFR Part 316.afety and effectiveness of a drug must be established through adequate and well-controlled studies. The Orphan Drug Act (ODA) provides for granting special status to a drug or biological product (âdrugâ) to treat a rare disease or condition upon request of a sponsor.