Replies to post #239152 on Elite Pharmaceuticals Inc (ELTP)

[lasers]

There was no such clinical trial info given otherwise, a new trial would already be on the FDA Clinical Trial website.


https://clinicaltrials.gov/ct2/results?term=%22elite+laboratories%22&Search=Search

[mrwrn2010]

My hunch was another BE trial would be required but it just seems asinine. You have a Phase 3 trial already proving that the drug works and is safe. Determining a "food effect" would technically be a Phase 1 trial.

www.fda.gov/downloads/Training/ClinicalInvestigatorTrainingCourse/UCM340007.pdf