3 ways FDA seeks to modernize its drug approval office

The FDA plans to modernize its Center for Drug Evaluation and Research's Office of New Drugs, which is responsible for reviewing and approving new medications.

FDA Commissioner Scott Gottlieb, MD, announced the proposed modernization plan June 4 via a statement on the agency's website.

"Some advances in our own processes are going to be achieved through more modern and scientifically rigorous approaches to how we collect and evaluate clinical data as part of the drug development process," he said. "But other features of our modernization require us to also change the way that we configure the structure and function of our process for reviewing this information."

Dr. Gottlieb outlined three ways the agency seeks to modernize the drug approval office:

1. Elevate the role of scientists and medical leaders. "We want to give our clinicians and scientists more time, better tools and greater support to advance the clinical and regulatory principles that the FDA uses to evaluate new drugs for safety and efficacy," Dr. Gottlieb said.

2. Update organizational structures to give review staff more time to assess clinical protocols and share feedback with drug companies. This structural change may include new therapeutic-specific divisions for distinct areas of medicine, according to Dr. Gottlieb.

3. Create a common review process that is more tightly integrated among all scientific disciplines. This change would also entail creating a common review template for FDA employees to use.  

"[W]e believe the new alignment and processes will improve efficiency by 20 percent at a minimum overall," Dr. Gottlieb said. "The additional efficiency we achieve will be channeled toward the development of more product guidance and thought leadership."

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