TMJ premarket applications based on historically controlled studies urged by TMJ Implants, Inc..
This article was originally published in The Gray Sheet
Executive SummaryUSE OF NON-RANDOMIZED, HISTORICALLY CONTROLLED STUDIES IN TMJ PMA submissions is urged by temporomandibular joint implant manufacturer TMJ Implants, Inc. in recent comments to FDA. Responding to FDA's July proposed call for premarket approval applications for partial and total TMJ prostheses, TMJ Implants notes that the preamendments devices have been marketed for over 30 years and "over this time" have become "an acceptable treatment regimen." Therefore, the firm reasons, a randomized trial with a concurrent control is not feasible since it would be impossible "to ask a physician to randomize a patient to [an alternative] treatment regimen that over time has shown to not be the treatment of choice in treating TMJ disorders."
You may also be interested in...
Oncology Center of Excellence is reviewing a research report on fluorouracil, and will next look to update cisplatin's label, but eventually must convince the reference product sponsor to submit the changes.
US FDA’s ‘Project Renewal’ requires lots of work and flexibility, Oncology Center of Excellence acknowledges. Side-benefit may be getting outside physicians to appreciate the value of drug labeling.
The pharmaceutical industry would lose bid to eliminate PUPSIT but win relaxed WFI in proposed EU GMP Annex I revision.