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The FDA’s draft guidance on cybersecurity for devices is a good start but needs some clarification, according to a working group of the International Organization for Standardization (ISO) and a variety of devicemakers. Read More
In the absence of a fully functional Eudamed database, the EU’s Medical Device Coordination Group (MDCG) says diagnostics companies should continue to follow individual national regulations for regulatory filings and other actions until the portal comes fully online in two years. Read More
To meet a requirement of the 21st Century Cures Act, the FDA is seeking comments for a report on the patient safety and best practices impact of nondevice software functions. Read More
The FDA’s review of proposed instructions for use (IFU) for a new drug, biologic or combination product will focus on accuracy and consistency with the agency-approved prescribing information, according to a final labeling guidance issued yesterday. Read More
A class action suit alleging deceptive marketing of several of Sanofi’s pain relief products will move forward following a federal district judge’s ruling Tuesday. Read More
Viatris, formerly Mylan, now must pay out a settlement of $264 million to consumers, insurers and pension funds who sued the company over steep price spikes for EpiPen, which is used to quickly administer epinephrine to treat potentially fatal allergic reactions. Read More