Your English writing platform
Discover LudwigExact(2)
The F.D.A. usually requires two positive clinical trials for approval.
The FDA said it would not require any more clinical trials for approval of the drug, but would need more non-clinical data.
Similar(58)
Objective To characterize the types of comparators and endpoints used in efficacy trials for approvals of supplemental indications, compared with the data supporting these drugs' originally approved indications.
A trial for approval as an early-stage diagnostic tool would take too long, they said.
The US trial for approval should begin someday soon.
A randomized placebo-controlled trial for approval in the U.S. is in progress.
The last trial type was used in a pivotal field trial for approval of imepitoin by the European Medicines Agency [20].
The company will begin its initial clinical trials for F.D.A. approval next year.
Replenish plans to enter trials for F.D.A. approval next year for a refillable and programmable pump that would be implanted in the eye to feed medicine for glaucoma or for age-related macular degeneration.
It might be easy to dismiss this as a sex toy, except that it's also in trials for Food and Drug Administration approval, and UroMetrics intends to distribute it only as a medical device via prescription.
"There is no damage to the hair follicles, so treating male faces is easy, safe and effective," explains Dr. Michael H. Gold, whose skin care center in Nashville (go to goldskincare.com) led clinical trials for F.D.A. approval of the technology.
Write better and faster with AI suggestions while staying true to your unique style.
Since I tried Ludwig back in 2017, I have been constantly using it in both editing and translation. Ever since, I suggest it to my translators at ProSciEditing.

Justyna Jupowicz-Kozak
CEO of Professional Science Editing for Scientists @ prosciediting.com