Goals: The purpose of this rotation is to familiarize the pharmacy student with the role of the Food and Drug Administration (FDA) during a drug or biologic product’s development and approval lifecycle. The DOP2 pharmacy student rotation will emphasize regulation of new drug or biologic products and review of new drug submissions. The DOP2 pharmacy student will gain professional experience from within the FDA’s Office of New Drugs
I. Learning Objectives: Upon completion of this rotation the student will be able to:
A. Describe the role of the FDA during the regulatory management of a new drug or biologic product.
B. Understand the drug review processes from initial submission to the time of approval, termination or withdrawal.
C. Apply knowledge that encompasses a mastery of FDA regulations, legislation, and administrative procedures involved in the drug approval process.
D. Discuss and identify the different types of FDA submissions in Investigational New Drug Applications (IND), Biologic License Applications (BLA), and New Drug Applications (NDA).
E. Understand regulatory requirements for drug approvals and the role of FDA guidance for industry documents to aid in the development of therapeutic products.
II. Student Requirements: The student will be exposed to a variety of regulatory management initiatives and electronic resources used during the premarket approval process for drug and biologic products. To meet the learning objectives listed above the student will be expected to:
A. Use online tools to research FDA drug regulations, standard operating procedures (MAPPs), and guidance documents to aid in the implementation and understanding of regulatory processes.
B. Attend bootcamps, briefings, advisory committees, seminars, division and office meetings
C. Independent learning
D. At the discretion of the preceptor, have the student or preceptor present regulatory topic reviews on topics not being presented in a format as noted above.
E. Give a presentation and/or conduct a project assigned by preceptors.
F. Attend FDA pharmacy student lectures.
G. Fulfill required student hours.