💊Executive Order on Pharmaceutical Supply Chain Resilience
Executive Order 14336 aims to strengthen the resilience of the American pharmaceutical supply chain by ensuring a stockpile of active pharmaceutical ingredients (APIs). It mandates the development of a critical drugs list and prioritizes domestic production, highlighting the government's efforts to enhance national security concerning essential medicines and medical countermeasures.
Learn More💊FDA Seeks Input on Onshoring Drug Manufacturing
The Food and Drug Administration (FDA, the Agency, or we) is announcing the establishment of a docket to solicit public comments on issues related to accelerating the establishment of new pharmaceutical manufacturing facilities in the United States. FDA is also announcing the following public meeting entitled "Onshoring Manufacturing of Drugs and Biological Products." At this meeting, FDA will present a draft framework that seeks to facilitate onshoring of pharmaceutical manufacturing. Participants will then engage in a guided discussion regarding the proposed framework, its strengths, weaknesses, and opportunities. The group will also discuss additional considerations that may help overcome current challenges faced by industry to onshoring the manufacturing of pharmaceuticals, including active pharmaceutical ingredients (APIs) and finished drug and biological products, and ideas and options within the bounds of FDA's statutory authority that could facilitate such onshoring of manufacturing.
Learn More💊Executive Order for Regulatory Relief in Pharmaceutical Production
Executive Order 14293 emphasizes the necessity of regulatory relief to support the domestic production of essential medicines. It outlines measures to streamline the review processes by key agencies like the FDA and EPA, aiming to eliminate barriers to pharmaceutical manufacturing. The order highlights a strategic initiative to secure a resilient domestic pharmaceutical supply chain and enhance national security.
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