HeyJaredAnna K. Abram
- Indexed articles, last 90 days
- 3
- Latest publication
- Aug 27, 2026
- Outlet visibility, for Mondaq
- Top 500K sites
- Earliest in this view
- Aug 10, 2026
Latest articles
PDUFA VIII Pushes Forward: Proposed Commitment Letter Outlines Updates To Drug Review Process (opens the original)
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Earlier this month, the U.S. Food and Drug Administration (FDA) released the proposed Prescription Drug User Fee Act (PDUFA) VIII commitment letter marking a pivotal milestone on the path to the seventh reauthorization of the agency’s program authorizing FDA to collect user fees to supplement the costs for the review of human drug applications. PDUFA VIII would span fiscal years 2028 through 2032, as the current authorization (PDUFA VII) is set to expire at the end of Fiscal Year 2027 (September
FDA Seeks Feedback On Proposed Quantitative Medicine Innovation Network (opens the original)
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The Food and Drug Administration (FDA) continued its efforts to modernize drug development and regulation with the recent publication of a notice in the Federal Register from the Center for Drug Evaluation and Research’s (CDER) Quantitative Medicine Center of Excellence announcing a request for information (RFI) to inform the development of the Quantitative Medicine Innovation Network (QMIN). The agency is seeking to better understand current quantitative medicine capabilities, challenges, and o
Congress Takes Action On FDA Bills Ahead Of August Recess (opens the original)
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The months and weeks leading up to August recess saw an uptick in activity by Congress on Health Care Legislation, including a focus on various aspects of Food and Drug Administration (FDA) policy. As part of this bipartisan, bicameral activity, both the House and Senate advanced FDA-related bills through various stages of the legislative process. There was a recurring focus on streamlining the path to approval for generic drugs and biosimilar products, as well as expediting the development and
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