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FDA

FDA Delays New Rule for Off-Label Promotion

[03/23/17]

Posted on March 23, 2017 in Health Law News

Published by: Hall Render

On March 20, 2017, the Food and Drug Administration (“FDA”) published a notice in the Federal Register delaying the implementation of the final rule (“Final Rule”) regulating off-label drug promotion until March 19, 2018. The Final Rule was published in the Federal Register of January 9, 2017. The effective date was originally delayed until... READ MORE

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FDA Again Delays Drug Product Tracing Obligations for Dispensers (Including Pharmacies and Physician Offices) to March 1, 2016

[11/02/15]

Posted on November 2, 2015 in Health Law News

Published by: Hall Render

Executive Summary On October 28, 2015, the Food and Drug Administration (“FDA”) revised its June 30, 2015 guidance delaying the enforcement of key track and trace requirements of the Drug Supply Chain Security Act (“DSCSA”) for Dispensers1 (including pharmacies, health systems and physician offices) until March 1, 2016 (“Guidance”). Previously, on June 30, 2015,... READ MORE

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FDA Delays Enforcement of Dispensers’ Drug Product Tracing Obligations Until November 1, 2015

[07/01/15]

Posted on July 1, 2015 in Health Law News

Published by: Hall Render

Executive Summary On June 30, 2015, the Food and Drug Administration (“FDA”) issued draft guidance delaying the enforcement of key track and trace requirements of the Drug Supply Chain Security Act (“DSCSA”) for Dispensers1 until November 1, 2015 (“Guidance”).  Specifically, the FDA indicated that it does not intend to take action against Dispensers that... READ MORE

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FDA Finalizes Guidance on Medical Device Data Systems

[02/10/15]

Posted on February 10, 2015 in Health Information Technology

Written by: Mark R. Dahlby

On February 6, the Food and Drug Administration (the “FDA” or “Agency”) released a finalized guidance (the “Guidance”) informing the public that the Agency does not intend to enforce any regulatory requirements applicable to several types of devices and software that transfer, store, convert, format and display medical data, specifically including medical image storage (“MIS”)... READ MORE

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New Guidance Documents from FDA Seek to Clarify Regulation for Wellness Devices and Medical Device Accessories

[02/10/15]

Posted on February 10, 2015 in Health Information Technology

Published by: Hall Render

On January 20, 2015, the Food and Drug Administration (the “FDA” or “Agency”) published two draft guidance documents designed to fulfill promises it made in the multi-agency Food and Drug Administration Safety and Innovation Act (“FDASIA”) Health IT report. The first draft guidance is intended to promote the innovation of general wellness devices and... READ MORE

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FDA, ONC and FCC Issue Long-Awaited Recommendations for Regulation of Health IT

[04/10/14]

Posted on April 10, 2014 in Health Information Technology

Written by: Mark R. Dahlby

Three federal regulators have released a long-awaited report proposing the framework for regulation of health information technology (“Health IT”).  The U.S. Food and Drug Administration (“FDA”), the Office of the National Coordinator for Health Information Technology (“ONC”) and the Federal Communications Commission (“FCC”) are accepting comments on their proposed risk-based regulatory framework until July... READ MORE

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Federal Regulators Accepting Comments on Health IT Regulatory Framework

[04/10/14]

Posted on April 10, 2014 in Health Information Technology

Written by: Mark R. Dahlby

The U.S. Food and Drug Administration (“FDA”), the Office of the National Coordinator for Health Information Technology (“ONC”) and the Federal Communications Commission (“FCC”) are accepting comments on their recently issued final FDASIA Health IT Report, entitled Proposed Strategy and Recommendations for a Risk-Based Framework. The agencies are seeking public comment on the questions... READ MORE

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FDASIA Report Tasks FDA with Clarifying Its Approach to Health IT

[04/10/14]

Posted on April 10, 2014 in Health Information Technology

Written by: Mark R. Dahlby

 On April 3, 2014, the U.S. Food and Drug Administration (“FDA”), the Office of the National Coordinator for Health Information Technology (“ONC”) and the Federal Communications Commission (“FCC”) released their long-awaited final report on health information technology (“Health IT”), entitled Proposed Strategy and Recommendations for a Risk-Based Framework. According to the report, the degree... READ MORE

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