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.
A sponsor seeking orphan designation for a drug must submit a request for designation to OOPD with the information required in 21 CFR 316.20 and 316.21. Each designation request must stand on its own merit.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.