Topics & People

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.

The official dietary guidance chart which Makary's FDA has 'flipped upside down' to prioritize protein over a historical focus on carbohydrates, citing decades of flawed science and industry influence.

The strategic rivalry between the United States and China for dominance in biopharma innovation, life sciences, and biomedical research.

The multi-stage process, including clinical trials, for getting new drugs to market. The FDA is reforming this process to reduce the typical 10-12 year timeline.

A series of 42 major changes implemented by Marty Makary at the FDA to challenge the status quo, increase efficiency, and accelerate the approval of drugs and therapies.