The FDA has proposed that the International Council on Harmonisation set global standards for generic drug developers, according to a report from FDA chief Dr. Scott Gottlieb. The U.S. regulatory agency argued that companies making generic drugs should be able to implement a single global drug development program and file for approval across multiple markets […]
FDA deals warning letter to Ocular over eye sealant
Ocular Therapeutix (NSDQ:OCUL) said today that it received a warning letter from the FDA over its ReSure hydrogel ocular wound sealant. The warning letter, dated Oct. 17, relates to Ocular’s compliance with data collection and reporting obligations in a post-approval device exposure registry study, according to the company. The registry study was a condition for approval […]
FDA launches pilot to expand special 510(k) market pathway
By Stewart Eisenhart, Emergo Group Medical device regulators at the US Food and Drug Administration has initiated a new pilot program for expanded eligibility in the agency’s Special 510(k) pathway, potentially easing market compliance requirements for more manufacturers whose devices have undergone modifications. Get the full story here at the Emergo Group’s blog. The opinions […]
What “no-deal” Brexit means for medical devices
India regulators update medical device and IVD oversight programs
By Stewart Eisenhart, Emergo Group Indian regulators have recently announced several updates regarding their medical device and IVD oversight programs. 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 approves five-year hormonal contraceptive
Allergan (NYSE:AGN) and the nonprofit women’s health pharma company Medicines360 said today that the FDA approved an application to extend the duration of use for Liletta for the prevention of pregnancy for up to five years. Medicines360 first won approval for the levonorgestrel-releasing intrauterine device in February of 2015. The system’s latest FDA approval is based on a […]
Kala seeks FDA nod for dry eye disease drug
Kala Pharmaceuticals (NSDQ:KALA) said today that it submitted a new drug application to the FDA for its KPI-121 0.25% topical product designed for patients with dry eye disease. The Waltham, Mass.-based company noted that roughly 33 million people in the U.S. have dry eye disease and nearly 90% of those patients experience flares in symptoms. Kala […]
U.S. regulators to overhaul third-party 510(k) review program
By Stewart Eisenhart, Emergo Group The US Food and Drug Administration has set a goal of obviating the need to re-review 85% or more of 510(k) applications that have undergone third-party review by the agency’s 2021 fiscal year. Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog post […]
Tandem wins approval for insulin pump in Canada
Tandem Diabetes Care (NSDQ:TNDM) won a medical device license from Health Canada last week for its t:slim X2 insulin pump. The device integrates directly with Dexcom‘s (NSDQ:DXCM) G5 continuous glucose monitor and is the only system of its kind approved in Canada, according to the San Diego, Calif.-based company. Tandem said it plans to launch the […]
FDA: TearLab’s Discovery MMP-9 test 510(k) fails to meet substantial equivalence
TearLab Corp. (OTC:TEAR) said this week that the FDA ruled that the company’s 510(k) submission for its TearLab Discovery MMP-9 test, designed to measure an inflammatory biomarker found in tears, did not meet criteria for substantial equivalence. The San Diego-based company’s TearLab Discovery lab-on-a-chip platform is intended to analyze multiple biomarkers in human tears with nanoliter […]
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