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News and Info

14 Jan

FDA Update – Recap of 2020

Over the past 10 months mdi has been actively assisting numerous companies with the EUAs for Masks, Gowns and Gloves as well as the Covid 19 tests. Several of our clients are included in the numbers provided by the FDA below. To look back on 2020, the FDA has released an infographic providing visualization of

23 Dec

FDA Update – FDA Warns Companies Illegally Selling CBD Products

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,

Dec

FDA Update – Human and Animal Food Facilities Biennial Registration Renewal

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

BREXIT and Medical Device Registration
07 Dec

Industry Update: Interesting news on – BREXIT and Medical Device Registration

As of January 1, 2021, the UK’s departure from the EU will begin. As of that date, the Medicines and Healthcare products Regulatory Agency (MHRA) will take on the responsibilities for the medical devices market for the UK that are currently undertaken through the EU system. This calls for several changes to how medical devices

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;

25 Nov

Clearing a Path for Financing by Investors

Angels, venture capitalists and strategic partners don’t want to commit financial resources to help a manufacturer develop a new medical device if they feel they will not get adequate return on investment in a reasonable timeframe. That makes perfectly good sense. Such a manufacturer must first perform a preliminary analysis as to whether their medical

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