Simplifying Global Compliance
Recommended Products
Effective 483 Responses: Focus on CAPA Violations
Everyone breathes a sigh of relief when the FDA investigators depart. But if they leave a Form 483 pointing out deficiencies and noncompliances, that’s when the work really starts.
Social Media Accountability for Drug and Devicemakers
No one seems to know what the rules of social media for life sciences are, including, some might say, the FDA itself.
Editor's Picks
Oxitone Medical Achieves FDA Clearance for Wrist-Sensor Pulse Oximetry Bracelet
The device measures critical vital signs such as SpO2 and pulse rate.
TGA Seeks Broader Authority to Penalize False Drug Advertising
TGA could require companies to provide documentation or evidence for a claim they made in advertising material.
EMA Annual Report Lists 27 New Active Substances, Highlights PRIME Pathway
The report highlights the launch of the PRIME expedited review pathway. Read More
Body Vision Medical Receives FDA Clearance for the LungVision Navigation System
The device allows physicians to track endobronchial tools and radiolucent lesions in real time. Read More
New Trump Administration, New Republican Congress - Webinar CD/Transcript
The US has a new president, a new Congress, and almost assuredly a new agenda for the FDA — with different policies and priorities than the current administration. What does this mean for FDA regulated industries?
ISO 13485:2016 — A Devicemaker’s Transition Guide
ISO 13485:2016 — A Devicemaker’s Transition Guide has done the work for you — saving you valuable time to make plans and put them in action. It has a clause-by-clause, line-by-line, 46-page comparison of the old and new versions of 13485 that shows you exactly what and where the new requirements are.
Clinical Research Manual
Clinical Research Manual brings together guidance on everything from pharmacokinetics and study design, to recruitment, monitoring, statistics… all the problem compliance areas you need to stay on top of to conduct clinical trials that will stand up to regulatory scrutiny.
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