By: Peter Marks, M.D., Ph.D. A little more than a year ago, FDA and NIH announced the availability of a draft template for investigators to use when organizing clinical trial protocols, which are essentially roadmaps for conducting a clinical trial. Today, we are excited to announce that the NIH-FDA Joint Leadership Council has issued a final […]
Regulatory/Compliance
Brazilian INMETRO certifications compliance deadline stays
By Stewart Eisenhart, Emergo Group Brazilian regulators are leaving in place the latest deadline of May 1, 2017 for new INMETRO certification requirements for some medical devices, despite extending this deadline twice in the past. Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog post are the author’s […]
New Brazilian sanitary licensing regulations for medical device companies
By Stewart Eisenhart, Emergo Group Brazilian medical device market regulator ANVISA has implemented new risk-based requirements for domestic companies to obtain sanitary licenses. 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 its employees.
FDA OKs BioDelivery Sciences’ Bunavail opioid dependence film
BioDelivery Sciences International (NSDQ:BDSI) said today that the FDA approved a supplemental new drug application for its Bunavail buprenorphine and naloxone buccal film. The revised indication allows patients to use the product to initiate buprenorphine treatment for opioid dependence. Induction is the initial process by which a patient transitions from abusing an opioid to buprenorphine […]
GE Healthcare wins FDA nod for Visipaque coronary CT angiography injection
GE Healthcare (NYSE:GE) said today that it won an indication approval from the FDA for its Visipaque injection imaging agent. The 320 milligram iodine per milliliter injection is an iso-osmolar agent that the federal watchdog approved for use in coronary computed tomography angiography. The new indication allows doctors to image coronary arteries of patients to help […]
UK medical device regulators replacing OBL with ‘Virtual Manufacturing’
By Stewart Eisenhart, Emergo Group Recent guidance from the Medicines & Healthcare Products Regulatory Agency (MHRA), the UK’s medical device market regulator, establishes the term “virtual manufacturing” to replace Own Brand Labeling (OBL) used by companies that place their names on devices made by other manufacturers. Get the full story here at the Emergo Group’s […]
Medtech stories we missed this week: April 28, 2017
From FDA and Health Canada approvals to joint ventures, here are medtech stories we missed this week but thought were still worth mentioning. 1. FDA clears Joimax Endovapor 2 Joimax announced in an April 26 press release that it has received FDA 510(k) clearance to market its Endovapor 2 Multi-Radio Frequency System. The device generates […]
Nordisk wins label update for weight loss drug-device combo
Novo Nordisk (NYSE:NVO) said today that the FDA approved an updated label for its Saxenda liraglutide weight loss medicine. The therapy’s new label will include data showing that half of patients who received Saxenda and lost at least 5% of their weight after 56 weeks maintained their weight loss for 3 years. The update is based […]
Sanofi, Regeneron win FDA nod for once-monthly cholesterol injection
Sanofi (NYSE:SNY) and Regeneron (NSDQ:REGN) said today that the FDA approved the companies’ new supplemental Biologics License Application for a once-monthly, 300 milligram dose of Praluent as a treatment for adults with high low-density lipoprotein cholesterol. The 300 milligram dose is administered using 2 pre-filled pens that each deliver 150 milligrams at an injection site. The […]
Portal wins ISO certification for needle-free drug delivery device
Medical device start-up Portal Instruments said today that it won ISO 13485:2012 certification from the National Standards Authority of Ireland. The Cambridge, Mass.-based company is developing a hand-held, needle-free drug delivery device. The device can precisely administer high viscosity biologics directly through the skin using a collimated jet that is the size of a strand […]
