On Friday, July 23rd, a bipartisan group of Senators introduced legislation that, if enacted, would require the manufacturers of e-cigarettes, vaping products, and other forms of electronic nicotine delivery systems (ENDS) to pay annual user fees to the Food and Drug...
Fee rates for OTC monograph drug facilities set by FDA.
UPDATE 04/01/2021:On March 30, 2021, FDA announced that they are further extending the UFI deadline for Food Facilities until December 31, 2022. This is the second extension of this kind in response to industry concerns that food facilities were unable to obtain a UFI...
UPDATE on Dec 30, 2020: FDA publishes new OTC drug user fees, read more here. Original Post Sept 9, 2020: On March 27, 2020, the President signed the Coronavirus Aid, Relief, and Economic Security Act (CARES Act) to aid response efforts and ease the economic impact of...
Beginning October 1, 2020, FDA will require a unique facility identification (UFI) number when registering food production facilities. Right now FDA has only approved Data Universal Numbering Systems (DUNS) numbers for use as UFIs for food facility registration. DUNS...
On September 12, 2019, the U.S. Food and Drug Administration (FDA) will begin removinginactive drug listings from its drug listing database. In other words, inactive drug listings will no longer be “listed” with FDA, as required by law. A removed drug listing can be...
Between October 1 and December 31, certain Food and Drug Administration (FDA)-registered facilities must renew their registrations. Here are some things you need to know to ensure your renewal is completed on time. Medical device establishments: The process of paying...
Between October 1 and December 31, Food and Drug Administration (FDA)-registered facilities must renew their registrations. Here are some things you need to know to ensure your renewal is completed on time. Medical device establishments: The process of paying...
Between October 1 and December 31, Food and Drug Administration (FDA)-registered facilities must renew their registrations. Our team has handled registration renewals for hundreds of facilities. Here are some things you need to know to ensure your renewal is completed...
Over the years we’ve worked with hundreds of companies to get their facilities registered and their products listed so they can meet their obligations, during which, we’ve come across a lot of misconceptions about registration. Here are some of the primary issues we...
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