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

Digital Health Companies May Find a Faster Path to Market Under the FDA's Digital Health Plan

It looks like the FDA is moving forward—and swiftly—with the digital health plan articulated in FDA Commissioner Scott Gottlieb's June blog post, previously outlined in this post. Closely tracking the commissioner’s post, the...more

FDA Exempts Numerous Medical Devices from 510(k) Premarket Notification Requirements

by Knobbe Martens on

The United States Food and Drug Administration (FDA) issued a Notice on July 11, 2017, exempting 1,003 Class II medical devices from premarket notification requirements under Section 510(k). The Notice indicates that anyone...more

Ninth Circuit Raises Bar for Approving Changes in State Medicaid Reimbursement

by Perkins Coie on

The U.S. Court of Appeals for the Ninth Circuit Court raised the bar last week for what states must prove to establish that their Medicaid provider reimbursement rates are sufficient to ensure a robust network of providers...more

Minnesota Patent Litigation Wrap-Up – July 2017

by Fish & Richardson on

This post continues our monthly summary of patent litigation in the District of Minnesota, including short summaries of substantive orders issued in pending cases. In July 2017, there were three notable decisions for...more

Health Alert (Australia) 7 August 2017

by DLA Piper on

In This Issue: - Judgments; Legislation; and Reports. - Excerpts from Judgments: 26 July 2017 - Spragg and Australian Health Practitioner Regulation Agency [2017] WASAT 103 - The applicant made a complaint to the...more

D.C. Circuit Decides Part C DSH Issue in Favor of Providers

by King & Spalding on

On July 25, 2017, the United States Court of Appeals for the District of Columbia Circuit held that HHS violated the terms of the Medicare statute by failing to undertake notice-and-comment rulemaking in implementing its...more

Baker Administration and Legislature Debate Range of Health Care Proposals

Massachusetts policymakers are currently engaged in a robust debate over several proposals aimed at lowering health care costs in the Commonwealth. The House of Representatives rejected a set of MassHealth reforms that the...more

Saudi Arabia Update - July 2017

by Dentons on

Legal Developments - Saudization in the Kingdom - Saudization is a colloquial term used to refer to the Kingdom’s official government policy of ensuring the hiring, training, and development of Saudi Arabian nationals...more

Health Alert (Australia) 24 July 2017

by DLA Piper on

In This Issue: - Judgments; Legislation; and Reports. - Excerpts from Judgments: 18 July 2017 - Ms Shahin Tavassoli v Bupa Aged Care Mosman [2017] FWC 3200 - Application for an unfair dismissal remedy. The...more

OIG Approves Cost-Sharing Arrangement Involving Clinical Research Study

by Baker Ober Health Law on

The U.S. Department of Health and Human Services, Office of the Inspector General (OIG), issued a favorable advisory opinion, No. 17-02, regarding a proposed arrangement under which the cost-sharing amounts owed by...more

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

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