I 3 Consulting

January 9, 2014

FDA DRUG ESTABLISHMENT REGISTRATION AND LISTING

Domestic and foreign establishments that manufacture, repack, or re-label drug products in the United States are required to register with the FDA. Domestic and foreign drug manufacturers, repackers or re-labelers are also required to list all of their commercially marketed drug products. This information helps the FDA maintain a catalog of all drugs in commercial distribution in the United States. Drug Registration and Listing System Fees – Click here
December 9, 2013

How to register facilities and products, and how to update registrations

Food Owners, operators, or agents in charge of domestic or foreign facilities that manufacture/process, pack, or hold food for consumption in the U.S. are required to register the facility with the FDA. Read more about fees >
November 9, 2013

Registration of Food Facilities

The Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (the Bioterrorism Act) directs the Food and Drug Administration (FDA), as the food regulatory agency of the Department of Health and Human Services, to take steps to protect the public from a threatened or actual terrorist attack on the U.S. food supply and other food-related emergencies. To carry out certain provisions of the Bioterrorism Act, FDA established regulations requiring that: Food facilities register […]
November 9, 2013

Drug Master File

The information contained in the Drug Master File (DMF) may be used to support an Investigational New Drug Application (IND), a New Drug Application (NDA), an Abbreviated New Drug Application (ANDA), another DMF, an Export Application or amendments and supplements to any of these. The US DMF contains factual and complete information on a drug product chemistry, manufacture, stability, purity, impurity profile, packaging, and the cGMP status of any human drug product.