Final Guidance

News & Analysis as of

White House Announces Release of Final Contractor Blacklisting Rules: Phased Implementation for Prime Contractors and...

The long wait for the so-called “contractor blacklisting” rules is over. According to a fact sheet released by the White House, final regulations and guidance will be released on August 24, 2016 and published in the Federal...more

White House Issues Final Guidance on Consideration of Greenhouse Gas Emissions in NEPA Reviews

After more than six years of review and the issuance of several draft guidance documents, the White House Council on Environmental Quality (CEQ) published on Aug. 5, 2016, its final guidance on considering greenhouse gas...more

Well, Well, Well – What Do We Have Here: FDA Eases Up On Regulating General Wellness Products

The Food and Drug Administration has issued guidance on general wellness products, which are low risk products it will not regulate as “medical devices.” A draft of the guidance was issued in January 2015, and the final...more

FDA Finalizes Wellness Product Guidance

The Food and Drug Administration Safety Innovation Act of 2012 (“FDASIA”) required a collaborative effort by the Food and Drug Administration (“FDA”), Federal Communications Commission and Office of the National Coordinator...more

NEPA guidance on greenhouse gas emissions

Federal agencies have new guidance on how to address the effects of greenhouse gas emissions and climate change as those agencies satisfy their duties under the National Environmental Policy Act. This month the White House...more

White House Issues Guidance Advising Agencies to Assess Climate Change in NEPA Reviews

On August 1, the White House Council on Environmental Quality (CEQ) issued its final guidance for federal agencies on considering greenhouse gas (GHG) emissions and the effects of climate change in National Environmental...more

Blog: All is Well:  FDA to Host Webinar on its Final Guidance for Low-Risk General Wellness Devices on September 1, 2016

The U.S. Food and Drug Administration (FDA) recently released final version of its guidance, General Wellness: Policy for Low-Risk Devices (Policy), with a webinar slated for September 1st as part of the rollout. While not...more

White House Issues Final Guidance on Climate Change Impact Analysis

On August 1, 2016, the White House Council on Environmental Quality (CEQ) released its final guidance on how and when federal agencies should consider the direct and indirect impacts from climate change, including from...more

FDA Issues Final Guidance on General Wellness Products

On July 28, 2016, the United States Food and Drug Administration (FDA) finalized guidance stating that the agency does not plan to regulate “general wellness products,” including software applications, provided they present a...more

White House Issues Final NEPA Guidance on Climate Change

On August 2, 2016, the White House Council on Environmental Quality (CEQ) issued its final guidance for federal agencies to assess the impact of their decisions on greenhouse gas emissions (GHGs) and also how such decisions...more

FDA Finalizes Guidance on Low Risk General Wellness Devices

On July 29, 2016, the US Food and Drug Administration (FDA) finalized General Wellness: Policy for Low Risk Devices Guidance (Final Guidance) detailing its risk-based regulatory approach to relax certain regulatory...more

CEQ Instructs Federal Agencies to Consider Climate Change Impacts During NEPA Reviews

On August 2, 2016, the Council on Environmental Quality (CEQ) released a Final Guidance for Federal Departments and Agencies on Consideration of Greenhouse Gas Emissions and the Effects of Climate Change in National...more

FDA Issues Final Guidance for General Wellness Devices

The final guidance confirms FDA’s enforcement discretion for many fitness and wellness technologies but raises issues for certain testing services. On July 29, the US Food and Drug Administration (FDA) announced the...more

FDA Regulatory and Compliance Monthly Recap – June 2016

FDA issues draft guidance to update policy on categorizing investigational device exemption devices to assist CMS coverage decisions - The draft guidance will amend the FDA’s 20-year-old policy for categorizing devices...more

FDA’s Final Guidance on Menu-Labeling Regulations and What It Means to Hotel Owners and Operators

Regular readers of this blog will know that we have been following the development and implementation of the FDA’s new menu-labeling regulations with some interest. After multiple rounds of drafts and public comment periods,...more

Don’t Mess With Texas: EEOC’s Criminal Background Check Guidance Subject To Challenge

On June 27, 2016, the U.S. Court of Appeals for the Fifth Circuit handed a victory to the State of Texas in Texas v. EEOC , No. 14-10949 (5th Cir. June 27, 2016), by remanding back to the district court the case it dismissed...more

FDA Issues New Form FDA 3926 and Final Guidance for Its Use, a New Approach for Physicians to Request FDA Approval for Expanded...

Agency Also Finalizes Additional Guidance Regarding Expanded Access (“Compassionate Use”) - On June 2, 2016, the Food and Drug Administration (FDA) issued final guidance “Individual Patient Expanded Access...more

FDA Finally Decides that “Evaporated Cane Juice” Is Misleading Consumers

Evaporated cane juice, a term usually used to inform about sweeteners derived from the fluid extract of sugar cane, is present on the ingredient lists of many products we see on grocery store shelves. However, newly finalized...more

U.S. FDA Finalizes Medical Foods Guidance

On May 12, 2016, the U.S. Food and Drug Administration (“FDA” or “Agency”) finalized its 2013 draft guidance for industry, “Frequently Asked Questions About Medical Foods; Second Edition.” Despite significant industry...more

FDA Releases Final Guidance Regarding the Food Labeling Term “Evaporated Cane Juice”

The US Food and Drug Administration (FDA) has released final guidance stating its view that sweeteners derived from sugar cane should not be declared in the statement of ingredients as “evaporated cane juice.” ...more

Final Policy Memorandum Provides Needed Predictability and Guidance on Job Portability Determinations

On March 18, 2016, United States Citizenship and Immigration Services (USCIS) released a final policy memorandum that offers guidance on determining whether a new job is in “the same or similar occupational classification”...more

Enforcement Date & Notable Differences In FDA’s Final Guidance For Menu Labeling

On May 5, 2016, FDA published a Notice of Availability (NOA) of its Final Guidance on menu labeling, entitled “Guidance for Industry: A Labeling Guide for Restaurants and Retail Establishments Selling Away-From-Home Foods -...more

FDA Finalizes Additional Guidance on Medical Foods; Continues to Take Narrow View of Category

FDA has finalized its guidance document relating to medical foods, a special class of products defined under the Orphan Drug Act. Although most of the content of the final guidance mirrors the draft guidance released in...more

FDA releases final guidance on menu labeling – new compliance date of May 2017 expected

The Food and Drug Administration has released its final guidance for industry on compliance with federal menu labeling laws. This highly anticipated document provides answers to many frequently asked questions and addresses...more

FDA Issues Final Menu Labeling Guidance

The U.S. Food and Drug Administration (FDA) announced on 29th April the publication of its final guidance for industry, “A Labeling Guide for Restaurants and Retail Establishments Selling Away-From-Home Foods – Part II (Menu...more

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