Overview
Final Project - Scientific Writings and Strategy Development Instructions
Final Project Purpose:
The purpose of this Assignment is to provide you with the opportunity to apply some advanced knowledge you gained from the course and to write and present your research in a manner expected from you as regulatory affairs professional. This includes being able to perform appropriate literature searches relevant to the topics being asked and locating the applicable guidance documents that can aid in constructing an appropriate regulatory strategy to address a certain need.
Provide a reference list with the references you identified from your literature search (please provide them in APA format).
Final Project Topic
PET (POSITRON EMISSION TOMOGRAPHY) is a medical imaging modality involving the use of a unique type of radiopharmaceutical drug product that contains a positron emitting isotope. The majority of PET drugs are injected intravenously into patients for diagnostic purposes.
Final Project Components
This Digital Prototype Assignment is split into 2 parts:
Part 1 (10%):
The objective of this portion will be to ensure that you perform comprehensive research on the topic in the assignment. Please answer the following questions for Part 1:
- What are PET drugs?
- History of the regulations of the PET drugs in context of US FDA.
- Identify at least 3 guidance documents issued by the FDA related to the PET drugs and explain their relevance to PET drugs regulations.
The Part 1 should consist of 500-1000 words (excluding references). Provide a reference list with the references you identified from your literature search in APA format.
Part 2 (20%):
On December 01, 2020, the U.S. Food and Drug Administration approved Gallium 68 PSMA-11 (Ga 68 PSMA-11) – the first drug for positron emission tomography (PET) imaging of prostate-specific membrane antigen (PSMA) positive lesions in men with prostate cancer.
By using the following links and the supporting documents provided, construct the approval package of Ga 68 PSMA-11 by answering the following questions:
- Complete the relevant sections in Form FDA-356h Application to Market a New Drug, Biologic, or An Antibiotic Drug For Human Use using the Form FDA-356h instructions.
- Chemical overview of Gallium 68 PSMA-11.
- Explain how safety and efficacy of Ga 68 PSMA-11 were evaluated in clinical trials.
- Production and Quality Control of Gallium 68 PSMA-11
- Briefly explain the Pharmacology and Pharmacokinetics of Gallium 68 PSMA-11
In addition, answer the following question in Part 2:
FDA approved Pylarify (piflufolastat F 18) – a drug for positron emission tomography (PET) imaging of prostate-specific membrane antigen (PSMA) positive lesions in men with prostate cancer. Pylarify received priority review designation for this approval.
Briefly explain why would FDA grant priority review to Pylarify?
The Part 2 should consist of 1000-1500 words (excluding references). The form FDA 356h is required to be completed separately. Provide a reference list with the references you identified from your literature search in APA format.
Links to complete Part 2:
Drug Approval Package: GALLIUM GA 68 PSMA-11 (fda.gov)
Supporting Documents provided:
- Form FDA-356h
- Form FDA-356h instructions
- Review [68Ga] Ga‐PSMA‐11: The First FDA‐Approved 68Ga‐Radiopharmaceutical for PET Imaging of Prostate Cancer