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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
In a survey by the consulting firm Deloitte, device manufacturers said that the semiconductors they need are in such short supply that many will have to cut back on production. Read More
Non-White patients experience less accurate oxygen readings with pulse oximeters and receive less supplemental oxygen in intensive care units, researchers reported in the journal JAMA Internal Medicine. Read More
Leading devicemakers have pushed back against the FDA’s proposed annual appraisals of companies that participate in the agency’s Voluntary Improvement Program (VIP). Read More