This article was originally published in The Gray Sheet
Coronary stent clinical trial is anticipated to commence later this year following investigational device exemption clearance from FDA, announced Nov. 17. The 15-site trial will include 400 patients with de novo lesions and 300 patients with acute and threatened vessel closure. The device utilizes a slotted tubular design to provide a low outside diameter profile
You may also be interested in...
In a statement submitted to the Senate Finance Committee, Natural Products Association CEO Dan Fabricant suggests two ways of improving compliance with new dietary ingredient notification requirements at negligible expense to the US FDA.
Public Company Edition: Legend Biotech raised $424m in its US public market debut. Also, Pfizer commits up to $500m for equity investments and Allogene capitalizes on ASCO with a $550m offering.
US FDA investigators are more likely to cite cell and gene therapy manufacturers for facilities and production deficiencies, agency says, while industry reports difficulties complying with drug GMP requirements that are not always applicable to cell and gene therapies.