FDA Commissioner Dr. Marty Makary: The agency could hit a record number of approvals this year

FDA Efficiency and Approval Process - FDA aims to shorten the drug approval time, currently over 10 years, by identifying and eliminating idle steps in the process [2] - FDA is considering continuous trials and reducing redundant application phases (pre-clinical, IND, phase one, phase two, FA) to accelerate drug development [3] - FDA is implementing a page limit for drug applications, similar to college applications, to enhance predictability and insight for drug makers [8] - FDA is using AI as an organizing tool in scientific reviews of drug applications, which can be up to 100,000 pages long [7][8] Transparency and Communication - FDA is releasing decision letters to improve transparency, allowing markets, companies, drug makers, and scientists to understand the review team's thinking in drug design [4] - FDA acknowledges the need for improved communication, suggesting even brief 15-minute calls with the scientific team could save companies a year of guesswork [4] - FDA aims to create more standardization and a culture of common standards to avoid reviewers acting with too much autonomy [6] Resource Management and Personnel - FDA Commissioner is assessing resource allocation to ensure scientists and inspectors have adequate resources, including 300 law enforcement officials [11][12] - FDA states that the agency will meet all targets for review decisions this year and potentially achieve a record number of approvals [14] - FDA clarifies there were no reductions in force or layoffs of scientific reviewers or inspectors [13] Leadership and Expertise - FDA emphasizes that the agency's strength does not rely on any single individual, highlighting the presence of over a thousand scientists in the relevant division [14] - FDA highlights the appointment of George Tidmarsh MD PhD, a drug developer with experience from both sides of the FDA and academic credentials from Stanford, as a top drug regulator [18]