UPDATE 03/29/2018: FDA has committed to well over 1,000 FSVP inspections this year, so the likelihood one will be at your office has increased significantly. The reach of the Food Safety Modernization Act (FSMA)...
A formal agreement between the U.S. Department of Agriculture (USDA) and the Food and Drug Administration (FDA) was announced on January 30, 2018 to increase coordination and cooperation between the two federal agencies. The agreement focuses on interagency...
The Food Safety and Inspection Service (FSIS) of the United States Department of Agriculture’s Directive 7120.1 will result, we expect, in a negative impact on trade at least related to the importation of catfish. FSIS’s 126-page directive is entitled the “Safe and...
UPDATE 01-31-2018 : Today FDA announced the first accredited body, ANSI-ASQ National Accreditation Board (ANAB), under the Accredited Third-Party Certification program. VQIP applications are now being accepted by the...
FDA announced that it will exercise enforcement discretion for certain provisions of the Food Safety Modernization Act, effective January 4th, 2018, until FDA decides on further action for each of the...
Drug pricing in the United States has been a complicated issue since the regulation of food and drugs begun in 1906. Understandably, high drug prices and efforts to bring them under control are hot topics in the news; it is estimated that prescription drugs account...
The National Oceanic and Atmospheric Administration (NOAA) will require a permit and additional data reporting for certain imported fish and fishery products. Starting January 1, 2018, failure to provide the appropriate permit information and/or sufficient...
President Trump has suggested a possible executive order to lower drug prices, which is to establish new trade policies that would strengthen intellectual property rights (IPR) in other countries markets. IPR refers to legal rights given to inventors or innovators of...
The Microneedling industry developed and flourished without any substantive guidance from FDA other than periodic whack-a-mole enforcement actions. That changed today (Sept. 14, 2017) with FDA issuing a DRAFT guidance with the captivating name: “Regulatory...
The US drug approval process is long and costly, and pharmaceutical development companies pass the extensive costs of research, user fees, and monopoly rent on to American consumers. Essentially, U.S. patients have been...
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