North America

FDA Issues Guidance on Therapeutic Protein Immunogenicity Tests

The FDA released guidance for sponsors of therapeutic proteins on developing tests to assess immunogenicity during clinical trials. Read More

New 510(k) Pathway Could Lead to Shorter Review Times, Experts Say

The FDA’s new Safety and Performance Based Pathway for 510(k) applications should be less burdensome than the longstanding Abbreviated 510(k) route to market. Read More

Shutdown That Curtailed Some FDA Inspections Ends – For Now

The FDA reopened on January 25 following a 35-day partial shutdown of the federal government that curtailed the agency’s inspection activities that did not directly tie into public safety. Read More

FDA Unveils Safety and Performance 510(k) Pathway

The FDA released details of its Abbreviated 510(k) review process, which it has renamed the Safety and Performance Based Pathway. Read More

FDA Revises Antimicrobial Drug/Device Guidance

The FDA released revised draft guidance on coordinated development of antimicrobial drugs and antimicrobial susceptibility test (AST) devices. Read More

AdvaMed Suggests Health Canada Modify 3D Printing Guidance

AdvaMed called for Health Canada to revise and clarify its draft guidance on licensing requirements for implantable devices made through 3D printing. Read More

FDA Expands Inspections as Shutdown Persists

As the partial government shutdown entered a record-setting fourth week, the FDA expanded high-risk inspection activities by bringing back more unpaid staff. Read More

FDA Lowers Risk Classification of Electroconvulsive Therapy Devices

The FDA has reclassified electroconvulsive therapy (ECT) devices that treat catatonia or severe major depressive episodes or bipolar disorder as moderate risk devices with special controls. Read More

FDA Scolds New Jersey Devicemaker for CAPA Handling

The FDA hit Monmouth Junction, New Jersey device manufacturer Replication Medical with a Form 483 following an inspection that revealed issues with the firm’s documentation of corrective and preventive action activities and device history records. Read More

Hemodialysis Solution Maker Dinged for Recurring Quality Issues

A 12-item 483 documents a litany of quality system failures the FDA found at Diasol East of Watertown, Tenn., during an Aug. 7 to Aug. 22 inspection. Read More