How long until widespread AI use comes to health systems?

The answer to this question depends, not only on how well AI tools work, but also on how AI technologies are regulated by the FDA. Scott Gottlieb has some thoughts on preferred regulatory approaches in his recent article in JAMA Health Forum. Artificial intelligence tools with advanced analytical capabilities used in clinical practice, especially tools…

57 new drugs were approved in 2024

That is according to the FDA. Nature Reviews Drug Discovery summarizes the progress to date as follows. The FDA’s Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER) approved 57 new therapeutic drugs (NTD) in 2024. This is slightly above the average of 53 NTDs per year for 2014–2024,…

Evolution of orphan drug

A study by Fermaglich and Miller (2023) evaluated trends in orphan drug designations and approvals after the Orphan Drug Act of 1983 was passed in the US. The authors use FDA data to evaluate between 1983 and 2022 and find that: Over the 40 years of the ODA, 6,340 orphan drug designations were granted, representing…

FDA’s Biosimilars Action Plan

In July 2018, FDA released the Biosimilars Action Plan (BAP), which outlined FDA’s approach for expanding access to biosimilars for the American public. The plan focused on 4 key areas: A recent FDA report reviews some of their accomplishments since then. Most of these efforts revolve around guidance documents, additional staff, education products and websites,…

Changes to the FDA Advisory Committee process

It appears changes are coming to the FDA Advisory Committee process for evaluating new drugs. The FDA is planning significant reforms to its advisory committee process, as announced by Commissioner Rob Califf. While specifics are scarce, these changes are spearheaded by Namandjé Bumpus, the FDA’s chief scientist, and newly appointed deputy commissioner.Califf noted improvements in…

Strong year for drug discovery

2023 was a strong year for drug discovery. Mullard et al. (2024) report: The FDA’s Center for Drug Evaluation and Research (CDER) approved 55 new drugs in 2023, as the small molecule and biologic pharmacopoeia continues to grow. This cohort is nearly 50% bigger than the new approval class of 2022, which fell below the…