CDER Releases Office of New Drugs 2023 Annual Report

FDA’s Center for Drug Evaluation and Research (CDER) has published the 2023 Office of New Drugs (OND) Annual Report. The report details the office’s major achievements of 2023, including notable drug approvals, publications, guidances, workshops, webinars, and meetings. Specifically, these achievements contain over 3400 formal meetings between sponsors of new drug development programs and CDER staff; 25 public Advisory Committee meetings; 55 novel drug approvals; 34 issued guidances; 651 OND speaking engagements; and OND representations at meetings, including Patient-Focused Drug Development meetings, Critical Path Innovation meetings, and Patient Listening Sessions.

Also featured are innovations in drug design and development, as well as OND’s partnerships with FDA and external stakeholders to tackle obstacles in drug development and regulation. The report demonstrates OND’s efforts in supporting drug development, pushing forward important drug approvals through substantial application reviews, using workshops and new guidances to promote policy, and maintaining careful post-approval drug assessments.

The report is largely divided into individual office reports, including the offices of: cardiology, hematology, endocrinology, and nephrology (OCHEN); drug evaluation sciences (ODES); immunology and inflammation (OII); infectious diseases (OID); neuroscience (ON); nonprescription drugs (ONPD); oncologic diseases (OOD); rare diseases, pediatrics, urologic and reproductive medicine (ORPURM); specialty medicine (OSM); therapeutic biologics and biosimilars (OTBB); and the non-clinical offices of program operations (OPO), regulatory operations (ORO), administrative operations (OAO), and new drug policy (ONDP). Each section includes a brief overview of the department, followed by its major achievements from the year. The report also features a message from the director, OND’s senior leadership team, an organizational chart of the office, publications from each office, and a list of acronyms and key terms.

Over 2023, OND organized 21 patient listening sessions, 18 of which were organized with the office of the commissioner and the office of patient affairs, and 3 of which were organized with professional affairs and stakeholder engagement. OND’s drug approvals in 2023 included new molecular entity (NME) new drug applications (NDAs), and biologics applications (BLAs), with additional efficacy supplement approvals and approvals to breakthrough therapy requests and fast track requests.

“This report documents the diverse efforts of OND staff, beyond the regulatory actions to approve important drugs,” stated Peter Stein, Director, Office of New Drugs in the report (1). “These efforts include holding many public meetings both to inform our OND staff of cutting edge science, and for OND staff to contribute to the knowledge of those in the pharmaceutical industry, in academics, and for patients and other stakeholder groups about advances in regulatory science, the biology of disease, and advances in clinical drug development; publishing numerous guidances that give insight to drug developers about the pathways and approaches to development that can provide the data FDA needs to support the effectiveness and safety of new drugs; the careful monitoring of drug safety post-approval to assure that drug’s prescribing information is kept updated with the safety information that health care practitioners and patients need.”

Reference

1. Center for Drug Evaluation and Research (CDER), 2023 OND Annual Report: Breaking Barriers to Advance Public Health(CDER, April 2024).