The Biotechnology Innovation Organization joined a host of other industry trade groups in sending a letter last week to federal, state and local officials asking them to adopt the Department of Homeland Security’s definition of “critical infrastructure” and commit to keeping critical manufacturing facilities open across the nation. The letter warned that well-intentioned actions – such as curfews, quarantines and shelter-in-place orders – being taken at the state and local levels “may fundamentally impede or otherwise threaten the supply of critical products.” Curfews that fail to consider transportation and workforce needs “could quickly become significant barriers to not only supply chains, but also actual supplies,” the groups said, adding that state and local governments must understand the need to transport products and have the workforce available to keep operations running. The letter calls for the president, governors and mayors to commit to not creating artificial barriers to the transportation of necessary products and to work in a coordinated fashion to ensure the safe shipment of goods from manufacturing facilities to retailers.
The Defense Logistics Agency, part of the U.S. Department of Defense, has modified an existing contract for the procurement of 8,000 ventilators from four vendors worth an estimated $84.4 million. This will be a time-phased delivery over the next several months, with orders expected to begin shipment within the next few days. About 1,400 are expected for delivery by early May. Delivery locations will be determined by the Federal Emergency Management Agency.
The U.S. FDA said Cme America’s class I recall of Bodyguard Infusion Pump Systems was initiated because the pumps may have a slower than expected delivery of medication (under-infusion), and faster than expected delivery of medication (over-infusion). The reason for the infusion errors is not known. Cme is a subsidiary of Franklin Lakes, N.J.-based Becton, Dickinson and Co.
The U.S. FDA is hosting an April 1 virtual town hall for clinical laboratories and commercial manufacturers that are developing or have developed diagnostic tests for SAR-CoV-2. The intent is to help answer technical questions about the development and validation of tests for SARS-CoV-2 and the recently issued guidance.
The U.S. FDA reported a June 9 public advisory committee meeting of the Ophthalmic Devices Panel of the Medical Devices Advisory Committee. The committee is slated to discuss, make recommendations, and vote on information regarding the premarket approval application (PMA) for the Visability Micro Insert sponsored by Refocus Group Inc. The proposed indication is for bilateral scleral implantation to improve unaided near vision in phakic, presbyopic patients between the ages of 45 and 60 years of age, who have a manifest spherical equivalent between -0.75D and +0.50 D with less than or equal to 1.00D of refractive cylinder in both eyes and require a minimum near correction of at least +1.25 D reading add.
A provider of medical diagnostic devices and services has agreed to settle U.S. Federal Trade Commission (FTC) allegations that it misled consumers about its participation in the EU-U.S. Privacy Shield framework. In a complaint, the FTC alleges that New Jersey-based Ortho-Clinical Diagnostics Inc. claimed that the company participated in the Privacy Shield framework and complied with the program’s requirements, even though the company had allowed its certification to lapse in 2018. As part of the settlement, Ortho is prohibited from misrepresenting its participation in the EU-U.S. Privacy Shield framework, as well as any other privacy or data security program sponsored by any government or self-regulatory or standard-setting organization. It also must either continue to apply the Privacy Shield protections to personal information it collected while participating in the program, or return or delete the information.
To expedite the development of COVID-19 diagnostics and therapies, Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) is shortening the clinical trial notification (CTN) timeline for starting first-in-human trials. Normally, a sponsor must submit a notification at least 30 days before the planned start date of a trial. The PMDA said it is waiving that 30-day period for COVID-19 products, so long as it has completed its review of the trial plan. “Currently, several CTNs for clinical trials for COVID-19 are being submitted and processed expeditiously,” the agency said. “All these efforts, among others, not only expedite development of products for COVID-19, but also provide the people affected with a variety of investigational medical products.”
The U.K.’s Medicines and Healthcare Products Regulatory Agency (MHRA) reported on March 31 that it has written to its phase I accredited units that are conducting early stage clinical trials to get confirmation that those trials have undergone a COVID-19 risk assessment. “All ongoing clinical trials should have already undergone a risk assessment in relation to COVID-19, including analysis of any potential risk to trial participants, in line with current government advice on social distancing and measures to reduce the spread of COVID-19,” the MHRA said. As a result of the new communication, which doesn’t apply to ongoing or proposed trials of COVID-19 therapies, “some trials may be temporarily halted or terminated, while some will continue if clearly justified, in order to protect or promote public and patient safety,” according to the MHRA.