June 4, 2018
Modernization effort at FDA’s Center for Drug Evaluation and Research (CDER)
Earlier today, Janet Woodcock, director of the FDA Center for Drug Evaluation and Research (CDER) announced a number of changes in her organization toward the goal of achieving more modern and scientifically rigorous approaches toward the collection and evaluation of data for the drug development process and, importantly, the organization and process by which this data is reviewed. As stated by FDA commissioner Scott Gotleib, ‘One principle aim of these proposed changes is to elevate the role of our scientists and medical officers to take on even more thought leadership in their fields.’ These changes seek to more tightly integrate the varied scientific disciplines important to the review such that the process is both more efficient and reflective of the most contemporary science.
Components of the proposed changes include:
- Recruiting the best and brightest individuals from many disciplines
- Enhancing our focus on multidisciplinary teams
- Prioritizing operational excellence
- Improving knowledge management
- Emphasizing the importance of safety across a drug’s lifecycle
- Incorporating the patient voice
With the ever-increasing advances in biomedical science, it is important that the regulatory review mechanisms evolve as well. Such scientific advances have created new opportunities for cures and treatments unimaginable only a few years earlier, but also present challenges of far greater complexity. It is important that the FDA, and other global regulators who closely follow the lead of FDA, continue to evolve and remain at the forefront of scientific understanding. These steps at CDER are timely and important.
Contributed by: Jim Audia
▸ FDA Proposes Process Modernization to Support New Drug Development.
Posted on June 4, 2018 by FDA Voice (www.fda.gov).
▸ Statement from FDA Commissioner Scott Gottlieb, M.D., on proposed modernization of FDA’s drug review office.
FDA Statement. Posted on June 4, 2018 (www.fda.gov).