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Stolen defective laryngoscopes offered for sale on Facebook Marketplace are now part of a manufacturer recall the FDA has deemed as class I, the most serious type of recall as use of the device could result in injuries or death. Read More
After 19 pilot programs conducted with medical device companies, regulators and patient communities, CDRH’s revised CAPA process is showing a 60 percent closure rate in under 60 days and a 50 percent overall reduction in improvement timelines, say FDA officials. Read More
As the first session of the 118th Congress continues, FDAnews will track important pending legislation, that has been acted on since July 1, to keep you updated on laws and regulations that could impact your business. Read More
In this edition of Quick Notes we tackle regulatory activity across the pond in Britain and the EU with stories on increased EMA fees, electronic product information for medicines, an updated service to help pharmaceutical companies and repurposing of a drug to help prevent breast cancer. Read More
The COVID-19 public health emergency may be officially over, but the temporary changes it provoked in regulatory assessments are here to stay, experts said during the 18th Annual FDA Inspections Summit last week. Read More
Over the past week, the FDA issued final guidance on real-time oncology review and cosmetic product facility registration and product listing. Read More
Attorneys general from 24 states and Washington, D.C. have sent the FDA a letter urging the agency to strengthen guidance and provide clear warning labels regarding incorrect pulse oximeter readings for patients of color. Read More
A sock that performs pulse oximetry measurement for infants will be available OTC for U.S. consumers by the end of this year, following the FDA’s Wednesday De Novo clearance of Owlet’s Dream Sock baby monitor. Read More
The FDA has extended the effective date of the guidance “COVID-19 Container Closure System and Component Changes: Glass Vials and Stoppers” until Aug. 7, 2024, unless a revised final guidance is issued before that date. Read More