Making European standards available to help address COVID-19
In response to the coronavirus outbreak, CEN, the European Committee for Standardization, and CENELEC, the European Committee for Electrotechnical Standardization, agreed to make freely available a series of European standards (ENs) formedical devices and personal protective equipment used in the context of the COVID-19 pandemic. "This exceptional decision is motivated by the need to tackle the severe shortage of protective masks and medical equipment experienced all around Europe due to the exponential growth of the COVID-19 emergency", the committees state. "The standards will enable a quicker and smoother access to market of new fundamental medical and protection equipment." The standards are available for free download from the websites of CEN national members.
Insulin Gains New Pathway to Increased Competition
In a landmark moment for patients with diabetes and other serious medical conditions, insulin and certain other biologic drugs transition to a different regulatory pathway, the U.S. Food and Drug Administration (FDA) announces. For the first time, a pathway will be open for products that are proposed as biosimilar to, or interchangeable with, the transitioned products. The availability of safe and effective biosimilar and interchangeable versions of these treatments, including insulin, is expected to increase patient access, adding more choices and potentially reducing costs of these vital therapies. More details on the FDA website.
Coronavirus update: FDA issues EUA to Hologic and LabCorp
The U.S. Food and Drug Administration (FDA) took two additional significant diagnostic actions during the coronavirus outbreak (COVID-19) by issuing Emergency Use Authorizations (EUAs) to: Hologic for its Panther Fusion SARS-COV-2 Assay, and Laboratory Corporation of America (LabCorp) for its COVID-19 RT-PCR test. “Staff at FDA have been working nonstop to expedite the review and authorization of diagnostics during this public health emergency,” said FDA Commissioner Stephen M. Hahn, M.D. “Since the beginning of this outbreak, more than 90 test developers have sought FDA guidance with the development and validation of tests they plan to bring through the EUA process. Additionally, more than 40 laboratories have notified us that they are testing or intend to begin testing soon under our new policy for laboratory-developed tests for this emergency. We stand ready to continue to support medical products in the pipeline to fight this virus.” More detailed information can be found on the FDA website.