Baxter Extraneal approval supported
This article was originally published in Pharmaceutical Approvals Monthly
Baxter's peritoneal dialysis solution Extraneal should be approved, FDA's Cardiovascular and Renal Drugs Advisory Committee concludes Aug. 9. FDA and the committee recommended long-term Phase IV trials of mortality
You may also be interested in...
In this new roundup feature focusing on the most notable developments in digital health, we pick the key news from the year so far.
US Regulatory Roundup, February 2021: QA/RA Predictions, FDA Warning Letter Stats, PMA Case Study, And More
Quality and regulatory predictions for 2021, a count of 2020 US FDA enforcement missives, a premarket approval case study for a novel prosthetic, and more topped our list of most-read Medtech Insight articles in February.
Locke Lord senior counsel Sharon Blinkoff shares perspective from her experience defending smaller cosmetics companies against US class action plaintiff demands and litigation.