Articles and Blogs

FDA

FDA Issues New Draft MOU for 503A Compounders Governing Cross-Border Dispensing and Comments Related to CGMP Compliance for Outsourcing Facilities

[11/02/18]

Posted on November 2, 2018 in Health Law News

Published by: Hall Render

On September 7, 2018, the United States Food and Drug Administration (“FDA”) issued a revised draft Memorandum of Understanding (“MOU”) that would govern interstate dispensing and distribution of “inordinate amounts” of compounded prescription drugs by certain compounding physicians and pharmacies. The concept of this MOU first appeared in the Compliance Policy Guidance issued by... READ MORE

Tags: , , , , ,

Department of Homeland Security and FDA Collaborate to Address Medical Device Cybersecurity

[11/02/18]

Posted on November 2, 2018 in Health Law News

Published by: Hall Render

On October 15, 2018, the National Protection and Programs Directorate (“NPPD”) of the U.S. Department of Homeland Security (“DHS”) and the U.S. Food and Drug Administration (“FDA”) entered into a Memorandum of Agreement (“MOA”) that formalizes a long-standing relationship between the agencies and implements a new framework for increased collaboration, information-sharing and coordination that... READ MORE

Tags: , , , , , , , ,

Final FDA Guidance on Interoperable Medical Devices

[09/20/17]

Posted on September 20, 2017 in Health Information Technology

Published by: Hall Render

On September 6, 2017, the U.S. Food and Drug Administration (“FDA”) published final guidance (“Guidance”) summarizing its recommendations for medical devices that are connected to each other and to other technology (“interoperable medical devices”). The Guidance finalizes preliminary guidance from January 2016 and is intended to encourage rapid innovation in the marketplace by allowing... READ MORE

Tags: , ,

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

Tags:

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

Tags:

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

Tags:

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

Tags: , , ,

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

Tags: , , , , , , ,

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

Tags:

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

Tags: