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FDA

Hall Render’s This Week in Washington – March 8, 2019

[03/08/19]

Posted on March 8, 2019 in Federal Advocacy

Published by: Hall Render

Congress Tackles Health-Related Issues in Multiple Hearings This Week Congress looked at many health policy issues in a week jam-packed with hearings. Continuing Congress’s probe into drug pricing, the House Ways and Means Health Subcommittee held a hearing on promoting competition to lower Medicare prescription drug costs. While lawmakers questioned whether the drug industry... READ MORE

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Digital Medicine: OIG Approves Arrangement to Provide Smartphones to Patients

[02/15/19]

Posted on February 15, 2019 in Health Law News

Published by: Hall Render

On January 29, 2019, the Department of Health and Human Services Office of Inspector General (“OIG”) published Advisory Opinion 19-02, which approved an arrangement allowing a pharmaceutical manufacturer to loan smartphones to financially needy patients in order to assist with medication adherence. OIG stated that it would not impose sanctions against the parties for... READ MORE

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FDA Clarifies Position on CBD After Passage of 2018 Farm Bill

[01/18/19]

Posted on January 18, 2019 in HR Insights for Health Care

Published by: Hall Render

The United States Food and Drug Administration (“FDA”) issued a statement (the “Statement”) clarifying its position on cannabidiol (“CBD”) products in the wake of the Agriculture Improvement Act of 2018 (the “2018 Farm Bill”) signed December 20, 2018.¹ The 2018 Farm Bill is a broad piece of legislation that regulates agricultural programs ranging from income support... READ MORE

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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

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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

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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

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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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