Biosimilar use may increase with scrutiny of high drug prices

USA – US Regulators Update Policies for Medical Device Voluntary Consensus Standards

EMERGO SUMMARY OF KEY POINTS: US FDA draft guidance explains agency’s process for recognizing voluntary consensus standards used for medical device declarations of conformity. ...
FDA Drafts Guidance on Enhancing Diversity in Clinical Trial Populations

USA – FDA Warns Against Using Implanted Pumps With Unapproved Drugs

The US Food and Drug Administration (FDA) on Wednesday warned physicians against using implantable pumps to deliver pain medications directly into patients’ spinal fluid...
Abbott's glucose monitoring system with real-time alarms wins EU nod

Europe – Abbott’s glucose monitoring system with real-time alarms wins EU nod

Abbott's FreeStyle Libre 2 glucose-monitoring system, which comes with optional real-time alarms for high and low glucose levels, has been granted a CE Mark for use...
Apple Sets the Stage for FDA Regulation on Two Types of AFib Mobile Medical Apps

USA – Apple Sets the Stage for FDA Regulation on Two Types of AFib...

The US Food and Drug Administration (FDA) granted two de novo classification requests on Tuesday on applications to be used with the Apple Watch...
Updated Fundamentals of US Regulatory Affairs Book

USA – Updated Fundamentals of US Regulatory Affairs Book

RAPS has just published the updated, 11th edition of Fundamentals of US Regulatory Affairs, the most extensive regulatory affairs textbook available, covering US regulations for...
Veta Smart Case for Epinephrine Auto Injectors Now Available

Canada – Veta Smart Case for Epinephrine Auto Injectors Now Available

Aterica, a Canadian company, is releasing its Veta smart case for epinephrine auto injectors (think EPIPEN). The device works in conjunction with a paired...
Wearable dialysis system gains breakthrough designation from FDA

USA – Wearable dialysis system gains breakthrough designation from FDA

AWAK Technologies recently announced the FDA has granted breakthrough device designation to its wearable PD system that incorporates AWAK’s sorbent technology. According to a company...
CDRH Finalizes Guidance on Diagnostic Ultrasound Systems and Transducers

USA – CDRH Draft Guidance Tackles Nitinol Devices

As part of a broader effort to address potential safety issues from materials in medical devices, the US Food and Drug Administration (FDA) proposed...
CDRH Finalizes Guidance on Diagnostic Ultrasound Systems and Transducers

USA – FDA Finalizes Guidance on Non-Clinical Bench Performance Test Reports for Device Submissions

The US Food and Drug Administration (FDA) on Friday finalized guidance on the content and format of non-clinical bench performance testing information to be...
Guidance Document: Management of Drug Submissions and Applications - Revisions

Canada – Drug and medical device highlights 2018: Helping you maintain and improve your...

The report gives information about new drugs and medical devices that Health Canada approved for sale in Canada, the information we published about potential...

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