New guidance on biologics affects authorized generics

USA – FDA finalizes guidance on machine learning for medical devices

The US Food and Drug Administration has finalized guidance on the regulation of software as a medical device (SaMD) that utilizes artificial intelligence or...

USA – Theranos : onze ans de prison contre Elizabeth Holmes, patronne déchue, condamnée...

L’ancienne star de la Silicon Valley Elizabeth Holmes, reconnue coupable de fraude en janvier, a été fixée sur sa peine, vendredi 18 novembre, près de...
Drugmakers Critique FDA Draft Guidance on Postapproval Changes for Drug Substances

USA – Diversity plan draft guidance on track before year end, FDA official says

The US Food and Drug Administration (FDA) is on track to publish a draft guidance on diversity plans before year’s end, which will take...
Biologic and Biosimilar Misinformation: FDA Drafts Guidance

USA – FDA eases review burden for certain sutures, orthopedic devices in leap-frog guidances

Two new guidances using the US Food and Drug Administration’s (FDA) safety and performance-based pathway make it easier for less complex sutures and orthopedic...

USA – Remote regulatory assessments: Pharma, device groups want more details on FDA guidance

Trade groups representing the pharmaceutical and medical device industries, while largely supporting the use of remote regulatory assessments (RRAs) as outlined in the US...

USA – Advocacy groups, AdvaMed vie for next phase of TAP pilot

Medical devices that treat brain diseases and disorders should be the next products to be accepted into a US Food and Drug Administration (FDA)...

USA – FDA moves forward with Voluntary Improvement Program to bolster medical device quality

The US Food and Drug Administration has issued new draft guidance to establish a full-blown voluntary program for improving quality-related processes in medical device...

USA – FDA proposes breakthrough status for devices that address health disparities

The US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) has proposed that devices that aim to eliminate disparities in...

USA – FDA draft guidance allows AI/ML devices to evolve without requiring new submissions

The US Food and Drug Administration (FDA) published a draft guidance outlining how sponsors of artificial intelligence and machine learning (AI/ML) products can submit...

USA – FDA eases UDI compliance requirements for some low-risk medical devices

The US Food and Drug Administration has exempted low-risk medical devices considered consumer health products from some Unique Device Identification compliance requirements in accordance...

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