Topics & People

The scientific field related to diet and health, which Marty Makary describes as one of the most corrupted fields, leading to flawed dietary guidance like the old Food Pyramid.

A law, signed by President Trump, that allows patients with life-threatening diseases to access experimental treatments that have not yet received full FDA approval.

The practice of monitoring the safety and efficacy of drugs after they have been approved and are in public use, which the FDA plans to enhance using big data and AI.

A proposed new paradigm for clinical research where data is monitored in real-time, rather than in discrete phases, to accelerate the drug development process.

A statistical method that allows for real-time analysis of clinical trial data, enabling faster identification of drug efficacy or safety signals. The FDA now allows its use.

An advanced lab technique where human cells (e.g., liver or heart cells) are grown to test drug toxicity, serving as an alternative to animal studies.

A modern technique using computers to predict a drug's effects, which is being used by the FDA to reduce the need for animal testing.

Large-scale (typically Phase 3) clinical trials required for drug approval. The FDA has changed the default requirement from two trials to one, a major cost and time-saving reform.

The duration of Phase 1, 2, and 3 trials required for drug approval, which the FDA aims to shorten significantly through various reforms.

A prestigious university and hospital system where Marty Makary had a clinical practice and served on the faculty of the School of Public Health.

A major economic and healthcare issue in the US. The Trump administration is taking steps to lower them through policies like Most Favored Nation pricing and promoting biosimilars.

The recommended timeline for childhood vaccinations. The FDA has revised this to a list of 'core essential vaccines' to rebuild public trust and align more with international standards.