Remove 2012 Remove Compliance Remove FDA
article thumbnail

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.

FDA 82
article thumbnail

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.

Doctors 123
Insiders

Sign Up for our Newsletter

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.

article thumbnail

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.

FDA 52
article thumbnail

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.

Hospitals 116
article thumbnail

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.

FDA 83
article thumbnail

Guest Post – Michigan Product Liability Law:  Retroactivity of New Law and Primer

Drug & Device Law

As the DDL blog has previously reported , Michigan’s longstanding presumption of non-defectiveness applicable to FDA-approved drugs was recently repealed by the Michigan legislature in S.B. As this provision is newly applicable to FDA-approved products, it has not been tested by the courts on this issue. 2d 279, 287 (Mich.

FDA 52
article thumbnail

Logical Contradiction Doctrine:  Buckman for Textualists

Drug & Device Law

470 (1996), was decided – removing express preemption as a defense for manufacturers of §510(k) products So defendants moved on fraud on the FDA under an implied preemption theory and won. Plaintiffs Legal Committee , 531 U.S. Mensing , 564 U.S. Mensing , 564 U.S. Lohr , 518 U.S.

FDA 72