#WorkforceWednesday: COVID-19 Pandemic, Election Rules Challenged, EEOC Limits GC’s Authority - Employment Law This Week®
Below is a tracker of healthcare-related executive orders (EOs) issued by the Trump administration, including overviews of each EO and the date each EO was signed. We will regularly update this tracker as additional EOs are...more
Senate Committees Continue Nomination Hearings. The Senate VA Committee held a hearing for VA secretary nominee Doug Collins and subsequently voted for his confirmation with broad bipartisan support. His confirmation vote...more
Holland & Knight Health Dose is an in-depth weekly dose of legislative and regulatory insights to keep stakeholders abreast of happenings in Washington, D.C., impacting the health sector....more
In this season of goodwill, gratitude, and giving, it's worth considering that both friends and strangers can have medical needs that we can ease with little pain or inconvenience to ourselves. Here's a sampling of five ways...more
In Washington - Friday afternoon, House Speaker Nancy Pelosi (D-CA) hosted a meeting with Senate Minority Leader Chuck Schumer (D-NY), White House Chief of Staff Mark Meadows, and Treasury Secretary Steven Mnuchin in a...more
Celltrion recently announced that its trastuzumab biosimilar, Herzuma, has met the World Health Organization’s (WHO) prequalification standards. WHO prequalification status is based on an assessment of the quality, safety,...more
Today, the World Health Organization (“WHO”) prequalified Samsung Bioepis’s breast cancer biosimilar trastuzumab – WHO’s first biosimilar prequalification. Prequalification is “a service provided by WHO to assess the...more
Although lawsuits can result in needed financial support and welcome recognition of harms suffered by patients seeking medical services, the civil justice system has its limits. They showed in cases in the news in which...more
The World Health Organization (WHO) announced today plans to launch a pilot project for prequalifying biosimilar medicines later this year. The project will initially focus on biosimilar versions of two cancer treatments,...more
On June 2, 2016, the FDA filed a notice for comments on guidance requesting that biologic applicants propose a suffix composed of four lowercase letters for use as the distinguishing identifier included in the proper name...more
On May 31, 2016, the FDA issued a notice that FDA’s Center for Biologics Evaluation and Research (FDA/CBER) intends to “enhance technical collaboration and cooperation between the FDA, WHO, and its member states to facilitate...more
The Federal Trade Commission (FTC) last week disputed the effectiveness and competitive impact of the Food and Drug Administration’s recently proposed biosimilar naming policy and argued that using different nonproprietary...more
On August 27, 2015, the U.S. Food and Drug Administration (FDA) released long-awaited and highly anticipated draft guidance regarding the non-proprietary naming of biological products, including biosimilars. The draft...more