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 […]
Regulatory/Compliance
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 […]
MDSAP status update for Australian medical device companies
By Stewart Eisenhart, Emergo Group Now that the Medical Device Single Audit Program has moved past its pilot phase in participating medical device markets, how are manufacturers and regulators warming to the program? Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog post are the author’s only and […]
EnGeneIC wins orphan drug designation for targeted nanocells
EnGeneIC said today that the FDA granted orphan drug designation to the company’s targeted EDV nanocells for the treatment of glioblastoma multiforme. The clinical stage biopharmaceutical company is developing bacterially-derived EDV nanocells as a nanoparticle, siRNA and miRNA delivery platform designed to target and kill tumor cells, while triggering the immune system’s natural anti-tumor response. […]
Aerie resubmits NDA for Rhopressa eye drops
Aerie Pharmaceuticals (NSDQ:AERI) said today that it resubmit a New Drug Application for the company’s Rhopressa eye drops. The Irvine, Calif.-based company’s NDA was withdrawn in October last year, after a contract manufacturer was not prepared for its pre-approval inspection. Aerie’s Rhopressa eye drops specifically target the eye’s trabecular network – the diseased tissue responsible for […]
Medical device companies face biggest challenges with regulatory compliance
By Stewart Eisenhart, Emergo Group Changing regulatory environments continue to present the biggest business challenge for a majority of medical device company senior managers, according to an annual Emergo industry survey. 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 […]
