In September 2019, the New Jersey Division of Rights (“DCR”) issued enforcement guidance (“Guidance”) clarifying and explaining how the DCR applies the state’s Law Against Discrimination (“LAD”) to discrimination based on hairstyles, particularly with respect to those “closely associated with Black people.” The Guidance states that the LAD’s prohibition on discrimination based on race encompasses discrimination that is ostensibly based on hairstyles that are inextricably intertwined with or closely associated with race and therefore prohibits ...
Earlier this month, the FDA released programmatic guidance intended to clarify the current review practices for the Humanitarian Device Exemption (“HDE”) Program (“Guidance”) reflecting recent changes in the HDE Program resulting from statutory amendments made by the 21st Century Cures. The Guidance addresses frequently asked questions about FDA actions on HDE applications, post-approval requirements, and includes a filing checklist to clarify the required information for the FDA to consider whether an HDE application is ready for substantive review.
Unlike ...
On April 30, 2019, Assistant Attorney General Brian Benczkowski announced that the Department of Justice (“DOJ”) had published an updated version of the Criminal Division's 2017 guidance publication “Evaluation of Corporate Compliance Programs.” In making the announcement, Assistant Attorney General Benczkowski said the update was designed to “better harmonize the prior Fraud Section publication with other Department guidance and legal standards.” He noted that DOJ also sought “to provide additional transparency in how [it] will analyze a company's ...
Our colleagues at Epstein Becker Green has a post on the Retail Labor and Employment Law blog that will be of interest to our readers in the health care industry: “NYC Commission on Human Rights Issues Guidance on Employers’ Obligations Under the City’s Disability Discrimination Laws.”
Following is an excerpt:
The New York City Commission on Human Rights (“Commission”) recently issued a 146-page guide titled “Legal Enforcement Guidance on Discrimination on the Basis of Disability” ...
On July 15, 2014, the U.S. Food and Drug Administration ("FDA") released draft guidance that provides extensive commentary on FDA's current thinking regarding the clinical trial informed consent process. Once finalized, this document, entitled "Informed Consent Information Sheet: Guidance for IRBs, Clinical Investigators, and Sponsors" ("Draft Guidance"), will replace FDA's 1998 informed consent guidance, "A Guide to Informed Consent."
Although the Draft Guidance is largely consistent with current practices a number of FDA's recommendations signal the modification ...
Earlier this week, a popular source of regulatory news published an article claiming FDA “finalized a new rule this week that prohibits manufacturers from using so-called “split-predicates”. However, it appears that the article may instead be referencing the Final Guidance for Industry and Food and Drug Administration Staff entitled “The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)]” that FDA published earlier this week. Unfortunately, as often occurs on the Internet, the post was disseminated by several other popular ...
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