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FDA took action earlier this week to relax regulatory standards for gowns, hoods, and surgeons’ and patient examination gloves during the pandemic.  The policy applies to the following products:

Table 1

Classification
Regulation
Device Type Product
Code6
Class
21 CFR 878.4040 Conductive Shoe and Shoe Cover BWP I (exempt)
21 CFR 878.4040 Operating-Room Shoes

FDA issued updated guidance regarding manufacture of alcohol-based hand sanitizerAs reports of hand sanitizer shortages have circulated and consumers have taken to using even Tito’s Vodka as a replacement (yes, on their hands), FDA has stepped in to provide clarity.  Last Friday, FDA issued updated guidance regarding manufacture of alcohol-based hand sanitizer.

The first guidance document, Temporary Policy for Preparation of Certain Alcohol-Based Hand

FDA Releases Industry Guidance Regarding Adverse Event Reporting During COVID-19On March 19, the Food and Drug Administration (FDA) released guidance providing recommendations to industry regarding postmarketing adverse event reporting for drugs, biologics, medical devices, combination products, and dietary supplements during a pandemic, including COVID-19. The guidance revises and replaces final guidance released in 2012 entitled “Postmarketing Adverse Event Reporting for Medical Products and Dietary

On the latest episode of the Ad Law Access Podcast, partner Kristi Wolff discusses FDA’s recent CBD warning letters, Commissioner nominee Dr. Stephen Hahn’s confirmation hearings, and a preview of this week’s Cannabis Law Update webinar.

On Thursday, December 5, from Noon – 1:00 Eastern we will be holding a webinar on the emerging

We’ve written a lot about FDA’s current position on CBD in food and the ongoing process to evaluate a potential non-drug pathway for the ingredient that emerged seemingly out of nowhere to capture the attention of consumers, legislators, and regulators alike.  While we all wait for FDA to announce an update to its review, states

As readers of this blog already may know, the Drug Enforcement Administration (DEA) currently allows cannabis – consisting of the marijuana plant, with greater than 0.3% THC content – to be grown for research purposes at only one location: The University of Mississippi. This past June, the Scottsdale Research Institute (SRI) challenged this federally-imposed

Last week, FDA Principal Deputy Commissioner and Acting Chief Information Officer Dr. Amy Abernethy released a series of tweets indicating that the agency is “expediting” its work towards addressing the confusion and uncertainty surrounding the regulation of hemp-derived CBD. Dr. Abernethy also stated that FDA plans to report on the agency’s progress around the end

On June 25, 2019, Senator Ron Wyden (D-OR) issued a letter urging Department of Health and Human Services (HHS) Secretary Alex Azar and Food and Drug Administration (FDA) Acting Commissioner Ned Sharpless to take action by addressing the confusion and uncertainty surrounding the regulation of hemp-derived CBD. Specifically, Senator Wyden requested that FDA issue guidance