Expanding on its commitment to facilitate the development and approval of safe and effective drugs for Americans with rare diseases, FDA is pleased to announce the newly-created position of Associate Director for Rare Diseases in the Agency’s Center for Drug Evaluation and Research’s (CDER’s) Office of New Drugs (OND). Dr. Anne Pariser, has been selected as the new Acting Associate Director for Rare Diseases and the Agency will move quickly to fill the position on a permanent basis. Dr. Pariser will report to the Director of the Office of New Drugs.
The Associate Director for Rare Diseases will serve as CDER’s focal point to the rare disease drug development community and assist stakeholders and developers of drug and biologic products in navigating the complex regulatory requirements for bringing safe and effective treatments to patients in need.
The Associate Director for Rare Diseases will also coordinate an initiative to develop CDER policies and procedures for the review and approval of treatments for rare diseases and to ensure appropriate training of CDER staff. An important focus of this new initiative will be to ensure collaboration among scientists and clinicians throughout CDER, to promote the adoption of new scientific and regulatory innovations that will help facilitate timely development and approval of new treatments for patients with rare diseases.