Opthea (ASX:OPT) said today that it received positive feedback from meetings with the U.K.’s Medicines and Healthcare Products Regulatory Agency and Sweden’s Medical Products Agency over its OPT-302 therapy for the treatment of wet age-related macular degeneration. The Australia-based company’s OPT-302 therapy consists of a soluble form of vascular endothelial growth factor receptor 3 that […]
Regulatory/Compliance
FDA proposes exempting 337 Class II devices from 510(k) requirements
By Stewart Eisenhart, Emergo Group US medical device regulators at the Food and Drug Administration (FDA) have proposed exempting hundreds of moderate-risk devices from 510(k) premarket notification requirements as the agency begins implementing components of the 21st Century Cures Act passed in late 2016. Get the full story here at the Emergo Group’s blog. The […]
No management support is common QMS audit problem
By Stewart Eisenhart, Emergo Group Undergoing an audit from a third party or conducting your own inspection of your medical device quality management system (QMS) can be a complex process with many moving parts—any of which can go wrong if not carefully monitored. Over a series of blog posts, we’ll discuss various common problems that […]
Study: Streamlined regulatory pathway has not shortened approval times for drugs
A study published by the Tufts Center for the Study of Drug Development found that the streamlined 505(b)(2) approval process for new drug applications in the U.S. has not led to shorter approval times. The 505(b)(2) pathway allows drug developers to seek FDA approval using safety and effectiveness data that was previously collected for a […]
PolyPid wins FDA designation for antibiotic drug reservoir
Pharmaceutical company PolyPid said today that its D-Plex antibiotic drug reservoir won Qualified Infectious Disease Product status from the FDA. Under the designation, the Israel-based company’s product will be eligible for priority review, fast-track status and an additional 5 years of market exclusivity. The D-Plex antibiotic drug reservoir is designed to prevent post-cardiac surgery sternal […]
Intersect ENT seeks FDA nod for Resolve steroid-releasing implant
Intersect ENT (NSDQ:XENT) said today that it submitted a New Drug Application to the FDA for its Resolve steroid-releasing implant to treat chronic sinusitis patients with recurrent sinus obstruction. The Menlo Park, Calif.-based company’s implant can be placed during a routine physician office visit and is designed to be a less invasive treatment option for recurrent […]
Brazilian ANVISA denies half of high risk medical device registrations in 2016
By Stewart Eisenhart, Emergo Group Nearly half of some higher-risk registro registration applications to Brazilian medical device regulator ANVISA were rejected in 2016, according to the agency’s own performance report. Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog post are the author’s only and do not necessarily […]
BTG wins CE Mark for DC Bead Lumi radiopaque drug-eluting bead
BTG (LON:BTG) said today that it won CE Mark clearance in the European Union for its DC Bead Lumi radiopaque drug-eluting bead. The bead is designed to be loaded with doxorubicin or irinotecan to locally treat tumors in patients with hepatocellular carcinoma and malignant colorectal cancer metastasised to the liver. The company’s DC Bead Lumi also […]
South Korean regulators clarify UDI, KGMP rules for medical devices
By Stewart Eisenhart, Emergo Group The South Korean Ministry of Food and Drug Safety (MFDS) has issued clarifications on medical device registration and quality system requirements whose enforcement dates are imminent. Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog post are the author’s only and do not […]
Mexican drug registration renewals now apply to medical devices
By Stewart Eisenhart, Emergo Group Recent changes to modification and renewal requirements for drug registrations in Mexico may soon apply to medical devices, as well. Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog post are the author’s only and do not necessarily reflect those of DrugDeliveryBusiness.com or […]
