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 […]
Regulatory/Compliance
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 The Irvine, Calif.-based company’s NDA was withdrawn in October last year, after a contract manufacturer was not prepared for its pre-approval inspection.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 […]
South African medical device companies have new licensing deadline
By Stewart Eisenhart, Emergo Group South Africa’s Medicines Control Council (MCC) has set a six-month deadline for domestic medical device and IVD manufacturers and distributors to apply for licensing in order to legally operate in the country. Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog post are […]
OncoSec wins fast track designation for electroporation combo therapy
OncoSec Medical (NSDQ:ONCS) said today that it won Fast Track Designation from the FDA for its ImmunoPulse IL-12 electroporation gene therapy for the treatment of metastatic melanoma. The biotech company’s electroporation device is designed to locally deliver DNA-based interleukin-12 to stimulate the immune system and fight off cancer cells. The ImmunoPulse device delivers a sequence […]
FDA accepts AcelRx’s NDA for Dsuvia pain reliever
AcelRx Pharmaceuticals (NSDQ:ACRX) said today that the FDA accepted the company’s New Drug Application for its Dsuvia pain relief therapy. The federal watchdog set a target decision date for October 12 this year. The company’s Dsuvia candidate is composed of 30 sufentanil tablets delivered sublingually using a disposable, pre-filled single-dose applicator to patients with moderate-to-severe […]
Intersect ENT wins FDA nod for Propel Contour steroid-releasing implant
Intersect ENT (NSDQ:XENT) said today that it won FDA approval for its Propel Contour steroid-releasing implant for the treatment of chronic sinusitis in the frontal and maxillary sinsuses. The Menlo Park, Calif.-based company’s portfolio of steroid-releasing implants are used in patients undergoing ethmoid, frontal or maxillary surgeries to treat chronic sinusitis. “The approval of Propel […]
Russian deadline for replacing old medical device license extended
By Stewart Eisenhart, Emergo Group The Russian government has pushed back a deadline for replacing medical device registration licenses issued before 2013 to December 2021 in order to harmonize requirements under the Eurasian Economic Union Agreement. Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog post are the […]
E.U. publishes final version of medical device regulations
Ronald Boumans, Emergo Final versions of the European Medical Device Regulations (MDR) and In Vitro Diagnostic Regulations (IVDR) have been published, and will come to a formal vote by the European Council on March 7 and by the European Parliament on March 20. Following these votes, the MDR and IVDR are expected to be formally published in late […]
