Focal's sealant to get expedited FDA review:
This article was originally published in Clinica
The premarket approval application for US firm Focal's FocalSeal-L surgical sealant has been accepted by the FDA under its expedited review procedures. FocalSeal is a synthetic absorbable liquid for sealing air leaks from the lungs during thoracic surgery. The sealant is sold in Europe under licence by Johnson & Johnson subsidiary Ethicon as AdvaSeal.
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.