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...
Globalization has brought U.S. consumers access to foods from around the world to satisfy any need or want, and as we’ve reported, food imports continue to surge. Increasing globalization has resulted in frameshifts in food production, including a transition from food...
FDA Regulation of Tobacco Products: Then The road to tobacco regulation has been a long one for FDA. Although the public health consequences of tobacco usage had been observed for several decades, FDA was not very involved in...
The U.S. Food and Drug Administration has two roles related to its food jurisdiction: (1) ensure food safety and (2) protect against consumer fraud or deception. Over FDA’s 110-year history, the Agency’s focus has oscillated between these two areas. Since the early...
The 21st century has brought us many new technologies that have improved lives, and now AdEchoTech has added one more innovation to the list: MELODY. 75 YEARS after the first sonography was used for medical diagnosis by neurologist Karl Dussick, AdEchoTech has...
The Food Safety Modernization Act’s (FSMA’s) staggered implementation continues with two new compliance events for the animal food industry starting yesterday, September 18, 2017. “Large” Facilities (500 or more employees) must comply with the Hazard Analysis and...
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 That changed today (Sept. 14, 2017) with FDA issuing a DRAFT guidance with the captivating name: “Regulatory...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...
FDA has begun inspecting U.S. food importers for their compliance with the Foreign Supplier Verification Program (FSVP). The FSVP regulation has a staggered compliance date between May 30, 2017 through July 27, 2020 (depending on the food type and the foreign...
Three experienced regulatory team members from FDAImports.com attended the Florida International Medical Expo (FIME) in Orlando with great success. We had excellent conversations with industry professionals all along the medical device development, production and...
Get up-to-date industry and regulatory news from the experts delivered straight to your inbox.