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Top FDA officials last week listened to stakeholder feedback on what has worked well and what can be improved in the Medical Device User Fee Amendments. Read More
Public Citizen has filed a petition urging the FDA to rescind its approval of the Seprafilm bioresorbable membrane, which is used to prevent postoperative adhesions, citing adverse patient events, including at least 21 deaths. Read More
India’s National Pharmaceutical Pricing Authority is asking several orthopedic implant manufacturers to provide details on cost increases that potentially may violate drug pricing laws. Read More
Starting in 2016, medical devicemakers supplying or manufacturing products in Ireland would be subject to a proposed fee-based system to cover the cost of the Health Products Regulatory Authority’s market surveillance activities. Read More
A federal judge in New Jersey has sentenced Charlie Chi, the former CEO of device startup OtisMed, to two years in prison for intentionally distributing a medical device whose marketing application had been rejected by the U.S. FDA. Read More
Ensuring efficient implementation of EU device regulations is a key activity the UK’s Medicines and Healthcare products Regulatory Agency has tasked for itself over the next year, according to a new business plan. Read More