Health Administrative Agency Science, Computers & Technology

Read need-to-know updates, commentary, and analysis on Health issues written by leading professionals.
News & Analysis as of

BREAKING NEWS: FDA Expected to Approve Amgen’s Humira Biosimilar Today

According to a report this morning from Seeking Alpha, FDA is expected to approve Amgen’s application for a biosimilar version of AbbVie’s Humira (adalimumab) today. If approved, it will be the first biosimilar adalimumab...more

CMS's Payment Suspensions Wreak Havoc: Understanding the Risks

CMS payment suspensions can cripple any provider's or supplier's operations. Yet, CMS has the authority to impose a payment suspension upon the mere existence of "reliable information" that an overpayment or fraud may exist....more

FDA Announces Upcoming Public Meeting on Its Recommendations for Reauthorizing the Biosimilar User Fee Act

Today FDA announced that it will hold a public meeting on October 20, 2016 to discuss its proposed recommendations for the reauthorization of the Biosimilar User Fee Act, which permits FDA to collect fees and use them for the...more

Off-Label Promotion —To Speak or Not To Speak?

Earlier this month, the U.S. Food and Drug Administration (FDA) announced a two day public hearing to take place November 9 and 10 aimed at obtaining input from industry to help shape FDA's policy regarding communications...more

FDA Call For Comments on Off-Label Communications

The FDA has announced a 2-day public hearing related to communications by manufacturers, packers, and distributors, regarding, in part, drugs licensed as biological products. There will be a particular focus on communications...more

Health Alert (Australia) August 29, 2016

In This Issue: - Judgments; Legislation; and Reports. - Excerpts from Judgments: 23 August 2016 - Secretary, Department of Health (as successor to the Secretary, Department of Social Services) v DLW...more

China FDA Clarifies Legal Consequences of Clinical Trial Data Inspections

China’s recent drug regulatory reform has emphasized that clinical trial data must be authentic and reliable. However, the legal consequences for breaching data integrity requirements in clinical trials remain ambiguous. On...more

HRSA Proposes Administrative Process to Resolve Disputes Between 340B Program Covered Entities and Drug Manufacturers

Taking a step toward completing a requirement imposed by the Affordable Care Act, the federal government has proposed regulations that would create an administrative dispute resolution (“ADR”) process to resolve disputes...more

FDA Issues Draft Guidance on "Deciding When to Submit a 510(k) for a Change to an Existing Medical Device"

On August 8, 2016, the U.S. Food and Drug Administration (FDA) issued draft guidance on the important topic of deciding when to submit a new 510(k) premarket notification application (510(k)) for a change to an existing...more

HHS Proposes Administrative Dispute Resolution Process for 340B-Related Claims

On August 12, 2016, the US Department of Health and Human Services (HHS) Health Resources and Services Administration issued a notice of proposed rulemaking that establishes an administrative dispute resolution process for...more

FDA Accepts Merck’s Lantus Biosimilar for Review

We recently posted that Merck had announced “promising” results from Phase III studies evaluating MK-1293, an investigational follow-on biologic insulin glargine candidate for the treatment of people with type 1 and type 2...more

Alert: FTC Commissioners Find LabMD's Failure to Implement Data Security Practices "Unfair"

On July 29, 2016, the Federal Trade Commission (FTC or Commission) announced its long-awaited decision in its LabMD enforcement action. The Commissioners reversed the decision of an Administrative Law Judge (ALJ) and held...more

Federal Trade Commission Holds Medical Laboratory Liable for Allegedly Unfair Data Security Practices

On July 29, the Federal Trade Commission (“FTC” or “Commission”) issued a unanimous Opinion and Final Order reversing the FTC Administrative Law Judge (“ALJ”) Initial Opinion issued November 13, 2015, which had dismissed the...more

FDA Isn't Moving to Regulate Devices that Track Fitness Regimes!

At long last, the Food and Drug Administration issued its Nonbinding Recommendations and Guidance regarding "General Wellness: Policy for Low Risk Devices," announcing it will not regulate "low-risk general wellness...more

FDA Issues Draft Guidance on Use of "Real-World Evidence" in Medical Device Decision-Making

The U.S. Food and Drug Administration (FDA) issued on July 27, 2016, a draft guidance document addressing how it may use data and evidence collected outside of the traditional clinical trial context to support medical device...more

USPTO Launches Patents 4 Patients

To support the National Cancer Moonshot initiative, the USPTO has launched the Patents 4 Patients program, also known as the Cancer Immunotherapy Pilot Program. Under this program, applicants can obtain expedited examination...more

Commission Holds FTC Unfairness Claim Does Not Require “Probable” or Tangible Injury in LabMD Data Security Case

The Federal Trade Commission unanimously (3-0) ruled on July 29, 2016 that LabMD’s data security practices were “unfair” under Section 5 of the FTC Act, reversing a decision of its Administrative Law Judge (ALJ). As we...more

LabMD Opinion Reverses ALJ Decision; Articulates Standard for “Substantial Injury” Under the Unfairness Prong of the FTC Act for...

In a widely anticipated move, the Federal Trade Commission (FTC) has overruled a decision by its own Administrative Law Judge (ALJ) that had dismissed a case against a medical testing laboratory accused of unreasonable data...more

Companies That Collect Sensitive Consumer Data Should Note the FTC’s LabMD Ruling

The FTC has been a leader in enforcing cybersecurity issues in recent years, and just last week it issued a highly-anticipated decision on its authority to regulate cybersecurity as a form of unfair consumer practice under...more

Breaking News: FTC Vacates ALJ’s Ruling and Finds LabMD Liable for Unfair Data Security Practices

In a ruling issued this morning, the Federal Trade Commission found that LabMD, the defunct Atlanta-based cancer detection lab, failed to protect patient information and is liable for unfair data security practices. The...more

Alabama Department of Revenue Now Argues that ALL Software—Canned or Custom—Is Subject to Sales/Use Tax

The Alabama Tax Tribunal (the “Tribunal”) ruled in a recent case that the taxpayer-hospital was entitled to a refund of the sales tax paid on the purchase of software that had been customized for its particular functions...more

Client Alert - The Government Makes a Business Associate Pay: What HIPAA Covered Entities and Business Associates Can Learn from...

The government has entered into its first settlement with a HIPAA business associate, including a $650,000.00 monetary penalty, ushering in a new period of enforcement for third parties who use Protected Health Information...more

FDA Reorganization Takes on Cancer Moonshot and Other Initiatives

On July 11, 1969, the United States accomplished the almost unthinkable –two men walking on the moon. Conjuring images of that moon landing, President Obama moved forward the “Cancer Moonshot” program at his January 2016...more

Teaming Up to Cure Cancer "Patents 4 Patients" – Fast Track Review

The United States Patent and Trademark Office “USPTO” is launching the “Patents 4 Patients” initiative, which will provide an accelerated review for methods of cancer treatments. Effective on June 29, 2016 the new “Cancer...more

Texas Medical Board Seeks State Action Immunity Protection in Fifth Circuit Brief

On June 17, the Texas Medical Board (“Board”) filed a brief with the Fifth Circuit Court of Appeals reiterating that the Board’s rulemaking processes are protected under the state action immunity doctrine, noting that the...more

864 Results
|
View per page
Page: of 35

Follow Health Updates on:

JD Supra Readers' Choice 2016 Awards

"My best business intelligence, in one easy email…"

Your first step to building a free, personalized, morning email brief covering pertinent authors and topics on JD Supra:

Sign up to create your digest using LinkedIn*

*By using the service, you signify your acceptance of JD Supra's Privacy Policy.

Already signed up? Log in here

*With LinkedIn, you don't need to create a separate login to manage your free JD Supra account, and we can make suggestions based on your needs and interests. We will not post anything on LinkedIn in your name. Or, sign up using your email address.
×