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FDA Considers New Approach to Improve Safe Disposal of Prescription Opioid Analgesics

Sharps Compliance

has decreased since 2012, it is still a sizable number. Since 2012, an estimated 140.6 Continue reading FDA Considers New Approach to Improve Safe Disposal of Prescription Opioid Analgesics at Sharps Compliance Blog. A Persistent Problem. Though the number of prescription opioids dispensed in the U.S.

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Visibly Launches Real-Time Video Consultations Through Merger With EyecareLive

Healthcare IT Today

As the developer of the world’s first FDA-cleared online visual acuity test, Visibly is committed to growing convenient access to quality vision care nationwide. Visibly , a leading healthcare technology company, is thrilled to announce the merger of Visibly and EyecareLive.

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FDA Guidance Provides Relief for MDR Reporting During a Pandemic

Exeed Regulatory Compliance

A new FDA guidance provides much-needed relief during a pandemic. FDA has just revised its relatively less known 2012 guidance entitled “Post-market Adverse Event Reporting for Medical Products and Dietary Supplements During an Influenza Pandemic” to clarify that the guidance is applicable to any pandemic, not just an influenza pandemic.

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HIMSS24 Roundup: M&A, Strategic Partnerships, Deployments, Product Launches, Funding, More

HIT Consultant

Transpara is FDA-approved and widely used by leading medical centers worldwide. By acquiring Triyam, Access leverages its existing expertise in records archiving and compliance management to offer a more comprehensive suite of solutions for healthcare organizations.

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SQA Regulatory Surveillance Summary 5 | Monthly Update 2021

SQA

Department of Health and Human Services (HHS) Office of the Assistant Secretary for Preparedness and Response (ASPR) and the United States Food and Drug Administration (FDA) released a series of policy recommendations to address the vulnerabilities in United States pharmaceutical supply chains. United States FDA – Guidances for Devices.

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Suing the Certifiers – A Dangerous Undertaking

Drug & Device Law

So if compliance with an industry standard is a defense, this plaintiff went a step further and sued the organizations that created the standards. 2012 WL 3265002, at *5 (N.D. 8, 2012) (“For claims against trade associations in particular, public policy is ‘part of the legal mix’ and favors not imposing a duty.”); Lockman v.

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Interesting Pelvic Mesh Due Process Certiorari Petition

Drug & Device Law

at 462-63; FDA §510(k) clearance of the defendants’ instructions for use did not “actually bar” or “clearly permit” the IFU statements so as to create a safe harbor that precluded the Attorney General’s claims, id. 239, 253 (2012) (which the Blog discussed here ). The bounds of statutory compliance are created entirely after the fact.

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