Sharps Compliance

MAY 11, 2022

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.

FDA 82

FDA Compliance 82

Healthcare IT Today

FEBRUARY 12, 2024

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.

Doctors 108

Doctors FDA Telemedicine HIPAA 108

Exeed Regulatory Compliance

MARCH 22, 2020

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.

FDA 52

FDA Nursing Homes Compliance COVID-19 52

HIT Consultant

MARCH 15, 2024

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.

Hospitals 116

Hospitals Medicare Medicare Doctors 116

SQA

AUGUST 2, 2021

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.

FDA 83

FDA COVID-19 Pharmaceutical Industry Hospitals 83

Drug & Device Law

DECEMBER 5, 2022

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.

Doctors 64

Doctors FDA Compliance 64

Drug & Device Law

AUGUST 8, 2022

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.

Doctors 52

Doctors Fraud Licensing Compliance 52