We have been warning clients on the use of CBD and the FDA regulatory requirements. You need to be very careful on the claims you want to make on your products that contain CBDs. Here is some recent FDA actions. The FDA has recently issues 5 warning letters to companies for violating Federal Food, Drug,
REMINDER FDA Update – Human and Animal Food Facilities Biennial Registration Renewal The FDA is reminding human and animal food facilities about this year’s biennial registration renewal period. These facilities, domestic and foreign, are that required to register with the U.S. FDA must renew their registration this year before December 31. The FDA will consider
The FDA has issued the guidance document, Conduct of Clinical Trials of Medical Products During COVID-19 Public Health Emergency, because the agency recognizes that the public health emergency caused by COVID-19 has impacted the conduct of clinical trials of medical products, including drugs, devices, and biologics. These challenges may arise from isolation practices, site closures,
The FDA has just launched a new program, the Innovative Science and Technology Approaches for New Drugs (ISTAND) pilot program. This program is meant for developers of novel drug development tools (DDTs), allowing pathways for those developers to submit proposals for novel approaches that are currently without an existing regulatory path. The existing DDT qualification
If you are unaware of the Voluntary Qualified Importer Program (VQIP), it is a voluntary fee-based program that allows for expedited review and import entry of food for humans and animals into the United States under the FDA Food and Safety Modernization Act (FSMA). The FDA has recently just approved 3 participants into this program;
Could this be the start of the FDA rescinding the EUAs? On October 15, 2020, the FDA reissued the EUA for certain filtering face-piece respirators (FFRs) manufactured in China which are not approved by the CDC’s National Institute for Occupational Safety and Health (NIOSH). The agency is reissuing this EUA to authorize only those types
This is very important information for foreign companies where we have observed many companies trying to get an edge by saying such terms as “FDA approved”, or “FDA CERTIFIED”. Make sure you read this. The FDA logo is made up of two components, the Monogram and Wordmark. The combination of the two components is what
FDA Update – October 19, 2020 FDA establishes U.S. Agent Voluntary Identification System for Food Facilities The FDA is issuing a new guidance document, U.S. Agent Voluntary Identification System (VIS) for Food Facility Registration. This is in conjunction with the FDA’s food facility registration database, the Food Facility Registration Module (FFRM). The purpose of the
Food companies please note The 2020 Biennial Registration Renewal Period began October 1, 2020 and concludes on December 31, 2020. Section 415 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) [21 U.S.C. 350d] requires food facilities required to register with FDA to renew such registrations during the period beginning on October 1 and
mdi predicated that the FDA would be closing these EUA down as soon as there are enough supply on the market. (https://mdiconsultants.com/life-after-the-eua/) The FDA monitors the 510(k) activity as we as the importing supply. The FDA has also been contacting companies to determine the amount of supply of various devices. This is the history of
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