FDA teams with India to stop counterfeit shipments

USA – FDA teams with India to stop counterfeit shipments

The U.S. Food and Drug Administration today announced that its first bilateral enforcement operation with the Government of India, stopped approximately 500 shipments of illicit,...
Modernizing ClinicalTrials.gov: NIH Seeks Feedbackowser for precision medicine research

USA – Modernizing ClinicalTrials.gov: NIH Seeks Feedback

As part of a multi-year modernization initiative, the National Institutes of Health’s (NH) National Library of Medicine (NLM) is seeking comments from users and...
Guidance Agenda: Guidance Documents CBER is Planning to Publish During Calendar Year 2020

USA – Guidance Agenda: Guidance Documents CBER is Planning to Publish During Calendar Year...

This is the list of guidance topics CBER is considering for development during Calendar Year 2020. The list includes topics that currently have no guidance...
Atherectomy 510(k) guidance finalized by FDA

USA – Atherectomy 510(k) guidance finalized by FDA

The US Food and Drug Administration (FDA) on Wednesday finalized guidance laying out its expectations for 510(k) submissions for peripheral vascular atherectomy devices, which...
Human Somatic Cell Therapy : Content and Review of Chemistry, Manufacturing, and Control (INDs)

USA – FDA issues progress report for ASCA medical device conformity assessment pilot

A new report from the US Food and Drug Administration on its Accreditation Scheme for Conformity Assessment (ASCA) pilot program explains the agency’s progress...
Human Somatic Cell Therapy : Content and Review of Chemistry, Manufacturing, and Control (INDs)

USA – FDA Drafts 510(k) Guidance for Arthroscopy Pump Tubing Sets

The US Food and Drug Administration (FDA) on Monday issued draft guidance explaining its expectations for premarket notification (510(k)) submissions for arthroscopy pump tubing...
FDA Classifies Three Radiology Devices Into Class II

USA – FDA Classifies Three Radiology Devices Into Class II

The US Food and Drug Administration (FDA) on Tuesday classified two software-based radiology devices into Class II (special controls) following requests for de novo classification from...
OAI Classifications for Drug, Device Facilities Decline Sharply Over Last 5 Years, FDA Data Show

USA – OAI Classifications for Drug, Device Facilities Decline Sharply Over Last 5 Years,...

As the spotlight on foreign drug and medical device facilities brightens because of impurity concerns and a lack of US Food and Drug Administration...
Ces lentilles connectées qui affichent des informations en réalité augmentée deviennent une réalité

USA – Ces lentilles connectées qui affichent des informations en réalité augmentée deviennent une...

Une société américaine, basée en Californie vient de présenter des lentilles de contact intelligentes qui sont capables d'afficher des informations sur un micro-écran de...
FDA finalizes guidance on clinical, in vitro drug interaction studies

USA – The FDA is Recommending Transition to New Duodenoscopes

Duodenoscopes play a vital role in the assessment and treatment of diseases and conditions of the pancreas and bile ducts, and are used in...

NOS PROCHAINES FORMATIONS