Biologics

How FDA ‘One-stop’ PJOs Help Combo Industry

A panel presentation at the 2023 AFDO/RAPS Healthcare Products Collaborative stressed the positive role FDA Project Jurisdiction Officers (PJO) play in coordinating the consideration of combination products. “The PJO is your best contact if you know, or think you know, your product’s Center or if you already have an IND application in-house and want to add to it,” said CDER combination product policy advisor Kristina Lauritsen.

Lauritsen said using the PJO as a one-stop information lead eliminates the need for sending multiple inquiries to different offices which, she cautioned, can lead to confusion rather than increasing the chance of getting the necessary information.

She also said the PJOs are in constant contact with the Office of Combination Products, which facilitates efficient communication.

Before or during a request for designation (RFD), Lauritsen said, the PJO will conduct an initial review, including background material and expert input. She said that while a pre-RFD or RFD is not a requirement, it can be useful in cases where there is uncertainty or disagreement about a product’s classification.

PJOs can answer questions about regulatory pathways, consult with other Centers, help with meeting requests, field questions about adverse event reporting, and provide advice on post-marketing safety reports, CGMP regulations, and patent and exclusivity issues, the panel said.

In addition to classifying medical products and facilitating communications between sponsors and regulatory offices, PJOs will assign combination and non-combination products to the appropriate Centers. “We can help you navigate concurrent submissions, which is actually really tricky,” Lauritsen said.

Amgen director of global and regulatory, and research and development policy Chelsea O’Connell told the audience about her experiences using a PJO to plot the regulatory course for a groundbreaking bladder cancer drug.

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome