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On December 26, 2023, the Food and Drug Administration (FDA) released a Small Entity Compliance Guide Final Guidance Document: Direct-to-Consumer Prescription Drug Advertisements: Presentation of the Major Statement in a...more
The Food and Drug Administration (“FDA”) released additional guidance documents on Wednesday, August 30th pertaining to the enhanced drug distribution security requirements under the Drug Supply Chain Security Act (“DSCSA”). ...more
On Friday, August 4th, the Food and Drug Administration (“FDA”) announced the availability of a final guidance document, titled “Waivers, Exceptions, and Exemptions From the Requirements of Section 582 of the Federal Food,...more
The U.S. Food and Drug Administration (FDA) issued a draft guidance document, June 27, that describes FDA’s current thinking on the prohibition of wholesaling human drugs by a 503B outsourcing facility under the Food, Drugs,...more
On May 10, the U.S. Food and Drug Administration (“FDA”) released a new guidance document Guidance for Industry: Testing of Glycerin, Propylene Glycol, Maltitol Solution, Hydrogenated Starch Hydrolysate, Sorbitol Solution,...more
The U.S. Food and Drug Administration (FDA or the Agency) published guidance regarding cybersecurity requirements for certain device premarket submissions (the Guidance). The Guidance outlines the implementation of new...more
The U.S. Food and Drug Administration (FDA) has issued new guidance to the medical device industry on the importance of cybersecurity measures in product development. ...more
On November 29, the U.S. Food and Drug Administration (FDA) issued two guidance documents about food allergen labeling requirements. First, FDA issued a draft guidance titled Questions and Answers Regarding Food Allergens,...more
Recently, the U.S. Food and Drug Administration (FDA) released two proposed rules that aim to clarify inconsistencies between FDA’s human subject protection regulations and the Federal Policy for the Protection of Human...more
The Food and Drug Administration (FDA) issued a guidance on development and emergency use authorization of diagnostic and serological tests for the monkeypox virus following the Secretary of the Department of Health and Human...more
On May 26, 2022, the Environmental Protection Agency’s Office of the General Counsel released EPA Legal Tools to Advance Environmental Justice (“EJ Legal Tools”). The document builds on and updates EPA’s 2011 Plan EJ 2014:...more
Originally published by Law360, Claudia Vetesi, Nicole Ozeran, and Lena Gankin authored an article discussing a wave of protein-labeling lawsuits hitting food manufacturers, alleging that their products’ front-label protein...more
On December 22, 2021, the Food and Drug Administration (FDA) published draft guidance documents for manufacturers of devices that were issued Emergency Use Authorizations (EUAs) or were subject to relaxed enforcement policies...more
As we enter our seventeenth month of the COVID-19 pandemic, fears that the pandemic is once again getting out of control continue to rise. With COVID-19 cases increasing across the country, due in part to the contagiousness...more
In a memo dated July 6, 2021, the DOJ’s Office of Legal Counsel concluded that the COVID-19 vaccines’ status as products authorized for emergency use does not prohibit public and private entities from requiring them as a...more
Yesterday, on July 27, 2021, the U.S. Center for Disease Control (CDC) issued new COVID-19 guidance, including recommending face masks even for vaccinated people when they are in indoor public settings in geographic areas...more
As disruption from the COVID-19 pandemic continues, pharmaceutical and medical device companies have been working hard to keep FDA-regulated clinical trials on track. Everyone involved in clinical trials should be acutely...more
The start-up segment of our healthcare regulatory practice is focused on companies bringing digital health tools to market. As part of the efforts of the U.S. Food and Drug Administration (“FDA” or the “agency”) to clarify...more
Two announcements made by FDA in late October signal a marked change to FDA’s regulatory approach to “homeopathic” drugs. On October 25, 2019, FDA withdrew the 1988 Compliance Policy Guide (“CPG”) 400.400 Conditions Under...more
On September 26, 2019, the US Food and Drug Administration (FDA) published six guidance documents clarifying its scope of authority and enforcement discretion policies in light of the 21st Century Cures Act (Cures Act). The...more
The U.S. Food and Drug Administration (FDA) has issued two new guidance documents related respectively to an “abbreviated” and a “special” approach to the typical 510(K) process for medical devices....more
Here are our picks for the most significant U.S. regulatory developments related to biosimilars in 2018: 1. FDA Releases Biosimilars Action Plan - In July, FDA released the Biosimilar Action Plan (BAP), which outlines...more
Today, the FDA issued four new biosimilar guidances, as well as a proposed rule. According to a statement by FDA Commissioner Scott Gottlieb, two of the guidance documents - the draft guidance titled “The ‘Deemed to be a...more
On March 29, 2018, the Consumer Financial Protection Bureau (CFPB) released two important implementation tools that may help mortgage servicers ensure compliance with recent amendments to the mortgage servicing rules in...more
FDA had a busy holiday season, issuing two final guidance documents and two draft guidance documents for industry related to human drug compounding right before the start of the new year. These guidance documents cover...more