Gilead’s Remdesivir Gains Orphan Drug Status as Possible COVID-19 Treatment
The FDA has granted Gilead’s remdesivir orphan drug designation as a potential treatment for COVID-19. Source: Devices & Diagnostics Letter
Denmark Expands Adverse Event Reporting Requirements
The agency said it wants to ensure that all incidents are fully investigated before any corrective actions are taken. Source: Devices & Diagnostics Letter
CDRH Extends Response Dates for Marketing Applications
For other submission types, “we encourage you to submit the response or report when possible,” CDRH said. Source: Devices & Diagnostics Letter
FDA Warns of Possible Failure of EpiPen Injectors
Some devices may not slide out of their carrier tube because of a deformation in the rim. Source: Devices & Diagnostics Letter
FDA Eases REMS Requirements During Coronavirus Outbreak
Sponsors who fail to meet certain Risk Evaluation and Mitigation Strategy (REMS) requirements won’t face FDA action during the COVID-19 outbreak, the agency announced. Source: Drug Industry Daily
NSAI Named 11th Notified Body Under EU MDR
The European Commission has authorized the National Standards Authority of Ireland (NSAI) as the 11th notified body under the EU’s Medical Device Regulation. Source: The GMP Letter
UK Introduces New Legislation to Overhaul Medical Device Authority
The UK government plans to update its regulatory framework for medical devices by the end of this year. Source: The GMP Letter
FDA Revises Guidance on 510(k)s for Atherectomy Devices
The FDA clarified what information devicemakers should include in their 510(k) premarket submissions for peripheral vascular atherectomy devices in a new final guidance. Source: The GMP Letter
483 Roundup: Six Devicemakers Cited for GMP Violations
The FDA cited six facilities for a variety of GMP lapses, including lax recordkeeping. Source: The GMP Letter
Korean Facility Warned for Repeat Violations
Serious quality system deficiencies that were repeat violations from a 2015 inspection landed Korean devicemaker Won Industry an FDA warning letter following an inspection of its Siheung-si, South Korea facility.…
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