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Category Archives: FDA Updates

23 Dec

FDA Update – FDA updates Q&A appendix in Guidance on Clinical Trials of Medical Products During COVID-19

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,

30 Nov

FDA Update – FDA launces new program to support use of Novel Drug Development Tools

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

Nov

FDA Update – Voluntary Qualified Importer Program Update

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;

FDA Logo Policy
19 Oct

FDA Update: FDA Logo Policy

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

Oct

FDA Update: FDA establishes U.S. Agent Voluntary Identification System for Food Facilities

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

05 Oct

FDA Update: 2020 Biennial FDA Food Facility Registration Biennial Renewal Notification

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

24 Sep

FDA Update: FDA Revokes Umbrella EUA for Infusion Pumps and Accessories

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

Sep

FDA Update: Recommendations About the Use of Dental Amalgam

The FDA has recently been made aware of potential adverse health effects of mercury exposure with the use of dental amalgam to certain groups. This is due to the mercury vapor (gas) released from the dental amalgam fillings. These groups include: Pregnant women and their developing fetuses; Women who are planning to become pregnant; Nursing

21 Sep

FDA Update: SARS-CoV-2 Reference Panel Comparative Data

Tuesday, September 15th, 2020, the FDA published comparative performance data for some authorized COVID-19 molecular diagnostic tests. The tables show the Limit of Detection (LoD) of more than 55 authorized molecular diagnostic COVID-19 tests against a standardized sample panel provided by the FDA. The FDA provided these standardized samples, known as a reference panel, to

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