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Read need-to-know updates, commentary, and analysis on Administrative Agency issues written by leading professionals.

FDA Makes Two Announcements on Electronic Tracking of Prescription Drugs to Comply with the Drug Supply Chain Security Act

by Hogan Lovells on

On July 20, 2017, FDA published two announcements in the Federal Register related to the development of an electronic, interoperable system to identify and trace certain prescription drugs distributed within the United...more

Dietary Supplement & Cosmetics Legal Bulletin | July 2017

JAMA Study and Editorial Call for Improvements in Cosmetic Regulation and Surveillance - In response to a study analyzing adverse events for cosmetics and personal care products, the Journal of the American Medical...more

Rare but Not Forgotten: FDA Speeds Review of Orphan Drug Requests

Ever heard of Hailey-Hailey Disease? How about factor V deficiency or Hemimegalencephaly? These are a few examples of rare diseases, e.g., those afflicting fewer than 200,000 Americans. Rare diseases have long had trouble...more

House Subcommittee on Health Opens Floor for Discussion of FDA Regulation of Off-Label Speech

by Hogan Lovells on

The House Subcommittee on Health has announced a hearing entitled “Examining Medical Product Manufacturer Communications” for Wednesday, July 12, 2017, at 10:15am EDT, in which it intends to examine two discussion-draft bills...more

Health Alert (Australia) 27 June 2017

by DLA Piper on

In This Issue: - Judgments; Legislation; and Reports. - Excerpts from Judgments: 22 June 2017 - Dorris Maharaj v Northern Health [2017] FWC 2997 - Application for relief from unfair dismissal – dismissal harsh,...more

Congressional Committees Advance Bipartisan FDA User Fee Agreements

by Baker Donelson on

On May 11 and June 7, the Senate HELP Committee and House Energy and Commerce Committee, respectively, both advanced bipartisan legislation to reauthorize four different user fee agreements that account for over a quarter of...more

FDA Requires Reprocessing Validation Data for Certain Reusable Devices

by Hogan Lovells on

On June 9, 2017, the U.S. Food and Drug Administration (“FDA”) published a Federal Register Notice announcing that new 510(k) notices for a number of reusable medical devices will now require the support of validated...more

Pennsylvania awards permits to 12 Grower/Processors

by Tucker Arensberg, P.C. on

The Pennsylvania Department of Health announced this afternoon the permits being awarded to the first 12 grower/processors for medical marijuana in the Commonwealth. As if announcing the 12 of the 177 applicants was not drama...more

NLRB Rules That Employers Have a Duty to Bargain Over ACA-Mandated Group Health Benefit Changes

On May 16, 2017, the National Labor Relations Board (“NLRB”) issued a decision holding an employer has the duty to bargain with a union over changes to a group health plan even though the changes were mandated by the...more

President’s Budget Proposes Significant Cuts to Healthcare Programs

by King & Spalding on

Released on May 23, 2017, President Trump’s proposed fiscal year (FY) 2018 budget would cut spending for healthcare programs. Specifically, the proposed budget would reduce funding for biomedical research, programs to fight...more

Gottlieb Announces New Regulatory Paradigm for Digital Health Software

by Hogan Lovells on

Recognizing both the opportunities and the potential regulatory challenges presented by such rapid development, the FDA – under the leadership of recently confirmed Commissioner Dr. Scott Gottlieb – is spearheading a new...more

To certify or not to certify? FDA has answered the question

by Hogan Lovells on

On June 7, 2017, FDA issued a revised guidance document, Form FDA 3674 – Certifications To Accompany Drug, Biological Product, and Device Applications/Submissions, to clarify when sponsors  should submit Form FDA 3674...more

FDA Pushes UDI System Compliance Date Back for Class I and Unclassified Devices

by Hogan Lovells on

On June 2, 2017, the U.S. Food and Drug Administration (FDA) announced in a letter to device labelers that it will issue a guidance document stating that FDA will exercise its enforcement discretion for the unique device...more

FDA Requests Painkiller Removed From the Market

by Dorsey & Whitney LLP on

The FDA has called on the drugmaker Endo Pharmaceuticals to stop selling the opioid Opana ER. The press release on June 8th reflecting this announcement marks a novel approach from the FDA, as the agency for the first time...more

Opioids: A First For The FDA

by Strasburger & Price, LLP on

On June 8, 2017, for the first time ever, the Food and Drug administration took “steps to remove a currently marketed opioid pain medication from sale due to the public health consequences of abuse.” The product is an opioid...more

WPI Insider Briefing: What Will the Second Hundred Days of the Trump Administration Hold?

by Littler on

From the workplace policy perspective, much of the focus of the first 100 days of the Trump administration was on confirming a new Secretary of Labor and reversing the Obama administration’s labor and employment agenda....more

ACA Retaliation Claim Survives Despite No Complaint About ACA Provisions

On April 28, 2017, the United States Department of Labor Administrative Review Board (“ARB”) allowed a whistleblower retaliation claim under the Patient Protection and Affordable Care Act (“ACA”) to proceed even though the...more

Part III: Stakeholder Comments on FDA’s Interchangeability Guidance for Biosimilars

This post, Part III, of a three-part series on FDA’s interchangeability draft guidance highlights a number of open issues that stakeholders have identified in their comments to FDA....more

Health Alert (Australia) 5 June 2017

by DLA Piper on

In This Issue: - Judgments; Legislation; and Reports. - Excerpts from Judgments: 26 May 2017 - Mrs Nicole Webb v The Trustee for SWC Unit Trust T/A Salisbury Day Surgery [2017] FWC 2573 - Application for relief from...more

Part II: Stakeholder Comments on FDA’s Interchangeability Guidance for Biosimilars

This post, Part II, of a three-part series (Part I) on FDA’s interchangeability draft guidance, highlights the key issues that were raised in the stakeholder comments provided to FDA. FDA received 52 comments in total from a...more

FDA Begins Reorganization that Will Affect How it Regulates Medical Technology

by Hogan Lovells on

What impact will the U.S. Food and Drug Administration’s significant reorganization efforts have on how the agency regulates medical technology? The agency is reorganizing the Office of Regulatory Affairs (ORA) and combining...more

Florida Board of Medicine to Hold Another Hearing on Telemedicine and Medical Marijuana Rules

by Foley & Lardner LLP on

On August 4, 2017, the Florida Board of Medicine will hold a third public hearing to discuss its proposed amendment to Florida’s telemedicine practice rules regarding medical marijuana. The Board held two prior public...more

Illinois Appellate Court Opens Door to Expanding List of Accepted Diseases in Medical Marijuana Program

by Wilson Elser on

On May 22, 2017, the Illinois First District Appellate Court upheld reversal of the Illinois Department of Public Health’s (IDPH’s) refusal to add chronic postoperative pain (CPOP) to the list of accepted diseases in the...more

Health Update - May 2017

Mapping the Healthcare M&A Landscape Under the New Administration - Editor’s Note: The healthcare M&A market continues to be among the most active sectors. In a recent webinar, Manatt examined how the policies and goals of...more

Manatt on Health Reform: Weekly Highlights - May 2017 #4

The President's budget proposes over $600 billion in Medicaid cuts on top of major reductions anticipated in repeal and replace legislation; the Trump Administration asks the Court for more time to decide on cost-sharing...more

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