FDA Publishes Guidance on Transdermal and Topical Delivery Systems
The guidance provides recommendations for the development and quality information that should be included in NDA and ANDA applications.
On Nov. 20, 2019, FDA published draft guidance recommending development and quality considerations for transdermal and topical delivery systems sponsors should include in new drug applications and abbreviated new drug applications. Specifically, the guidance describes recommendations for product design and pharmaceutical development, manufacturing process and control, and finished product control. Areas where quality is closely tied to product performance and safety (e.g., adhesion failure and impacts of applied heat) are also addressed.
Source: FDA
Pharmaceutical Tariffs Are Imminent: How Industry is Bracing for Impact
April 16th 2025On April 14, 2025, the Trump Administration launched a national security-driven investigation into pharmaceuticals, a move that will likely result in tariffs being placed on pharmaceutical drugs, ingredients, and other components that are imported from outside of the United States.
