Chapter 4: Jurisdiction and Regulatory Pathway
38
is requested after submission of the Pre-RFD
but prior to OCP’s feedback, the meeting could
potentially extend the review timeline for the
Pre-RFD. OCP will require four weeks prior to
the meeting to review any data or information
submitted as part of the meeting request.23 A
comprehensive background package provided
at the time of the meeting request is imperative
for a timely and thorough OCP review. The
background information package should be clear,
concise, and focused, without extraneous and
irrelevant information or data. OCP cannot pro-
vide meaningful feedback during a meeting if the
background package is inadequate this will cause
unnecessary delays. See Figure 4-1 for a diagram
of the Pre-RFD process.
Intercenter Agreements: Jurisdiction
Many resources are available to help sponsors
understand a combination product’s jurisdiction.
The original resources were the three intercenter
agreements (ICAs) established in 1991 between
the following:
• CBER and CDER
• CDER and CDRH
• CBER and CDRH
The ICAs’ usefulness has decreased over time
due to agency organizational realignments, the
development of new products not envisioned in
the original ICAs, new uses of existing prod-
ucts, and laws enacted since 1991. In the 2006
Federal Register the agency announced it had
reviewed these agreements and preliminarily
proposed continuing to use the CBER-CDRH
and CDER-CDRH ICAs, as they provide
helpful, nonbinding guidance, with the under-
standing that they should not be relied upon as
the agency’s most current, complete jurisdictional
statements. Due to the transfer of many thera-
peutic biological products from CBER to CDER
in 2003, the agency stated the CBER-CDER
ICA was out of date.
Figure 4-1. Pre-RFD Process Flow
Source: How to Prepare a Pre-Request for Designation (Pre-RFD): Guidance for Industry. February 2018. Final. FDA website.
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/how-prepare-pre-request-designation-pre-rfd.
Accessed 19 March 2021
38
is requested after submission of the Pre-RFD
but prior to OCP’s feedback, the meeting could
potentially extend the review timeline for the
Pre-RFD. OCP will require four weeks prior to
the meeting to review any data or information
submitted as part of the meeting request.23 A
comprehensive background package provided
at the time of the meeting request is imperative
for a timely and thorough OCP review. The
background information package should be clear,
concise, and focused, without extraneous and
irrelevant information or data. OCP cannot pro-
vide meaningful feedback during a meeting if the
background package is inadequate this will cause
unnecessary delays. See Figure 4-1 for a diagram
of the Pre-RFD process.
Intercenter Agreements: Jurisdiction
Many resources are available to help sponsors
understand a combination product’s jurisdiction.
The original resources were the three intercenter
agreements (ICAs) established in 1991 between
the following:
• CBER and CDER
• CDER and CDRH
• CBER and CDRH
The ICAs’ usefulness has decreased over time
due to agency organizational realignments, the
development of new products not envisioned in
the original ICAs, new uses of existing prod-
ucts, and laws enacted since 1991. In the 2006
Federal Register the agency announced it had
reviewed these agreements and preliminarily
proposed continuing to use the CBER-CDRH
and CDER-CDRH ICAs, as they provide
helpful, nonbinding guidance, with the under-
standing that they should not be relied upon as
the agency’s most current, complete jurisdictional
statements. Due to the transfer of many thera-
peutic biological products from CBER to CDER
in 2003, the agency stated the CBER-CDER
ICA was out of date.
Figure 4-1. Pre-RFD Process Flow
Source: How to Prepare a Pre-Request for Designation (Pre-RFD): Guidance for Industry. February 2018. Final. FDA website.
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/how-prepare-pre-request-designation-pre-rfd.
Accessed 19 March 2021