October 6, 2020
Last week, FDA issued a final rule regarding the importation of certain prescription drugs from Canada. This action was taken by the agency as part of the Safe Important Action Plan, and was done in an attempt to provide safe, effective, and more affordable drugs to Americans.
The final rule was published alongside a final guidance document and outlines all requirements that Sponsors must include in their importation plan.
Are you interested in importing an approved product to the United States from Canada? We can assist you throughout the entire process, using science to help you achieve successful interactions with FDA. To learn more about our services and how we can help you, contact us today.
TAGS: Regulatory Sciences
April 18, 2016
On December 23, 2015, the FDA announced a proposed rule regarding the regulation of fixed-combination drugs. In its announcement, FDA proposed that its requirements for prescription fixed-combination...
November 13, 2023
The FDA's Breakthrough Devices Program is intended to expedite the development of innovative technologies for patients with life-threatening or irreversibly debilitating diseases or conditions. The...
May 14, 2015
In a final guidance published in the Federal Register on May 5, FDA laid out the rules and specifications for providing regulatory submissions in electronic format. Perhaps more important than the...