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Regulatory Affairs Unit
The RSC
Regulatory Affairs Unit is responsible for the filing and oversight of all UAMS
Investigator Initiated Investigational New Drug (IND) applications and
applicable Medical Device applications. If you are a researcher, doing
investigator-initiated research on the UAMS campus, and an IND is required for
your study or a medical device is being altered from its original approval: UAMS
will act as the sponsor. We ensure that all IND and medical device studies
remain in compliance as required by the federal regulations under Title 21 of
the Code of Federal Regulations.
Regulatory Affairs Staff:
Links:
Investigational New Drug Studies (IND):
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Regulatory Strategy
– The Regulatory Affairs Staff assists in helping investigators with all of
their regulatory needs throughout their series of investigations.
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FDA Interaction
– It is beneficial to seek FDA input at various intervals, and all
communication or correspondence with this government agency is conducted by
the Regulatory Affairs Staff or coordinated through their services. Examples
include submissions, teleconferences, and meetings.
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Regulatory Review
– The Regulatory Affairs Staff will perform a review of the clinical
protocol to determine if an IND or IND exemption may be needed.
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IND – An
IND will be needed if you are: using a new chemical/biological entity, using
a marketed drug in support of a different indication, or significantly
increasing the risks associated with the use of the drug product (route of
administration, dosage level, patient population, etc.)
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IND Exemption
– An IND exemption may be requested if the drug is lawfully marketed in the
United States and meets the following requirements: the investigation is not
intended to be reported to the FDA as a well controlled study in support of
a new indication nor intended to change the labeling OR the
investigation does not involve a route of administration or dosage level or
use in a patient population or other risk factor that significantly
increases the risks or decreases the acceptability of the risks.
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Filing
and Maintenance
– The Regulatory Affairs Staff can assist the investigators in the
preparation, filing, and maintenance of all of the applicable regulatory
documents required to be submitted to the FDA. We will maintain the
regulatory relationship between UAMS and the Food and Drug Administration
(FDA) throughout the trials, relieving the investigator of the regulatory
requirements.
Investigational Device Studies:
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Regulatory Strategy-
We assist in planning for the regulatory needs throughout a product’s
development lifecycle or throughout a series of investigations.
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FDA Interaction-
It is beneficial to seek FDA input at various intervals, and all
communication or correspondence with this government agency is conducted by
the Regulatory Affairs Staff or coordinated through their services.
Examples include submissions, teleconferences, and meetings.
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Risk Determinations and Project Evaluation-
It is necessary for each device study to be evaluated by the sponsor (UAMS)
for the device’s risk determination and regulatory responsibilities. This
evaluation is coordinated through the Regulatory Affairs Unit. If there is
a question of risk determination or project evaluation that is felt to need
FDA insight, this is also handled by the Regulatory Affairs Unit.
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Non-Significant Risk Device Investigations-
These investigations are thought to be ones of non-significant risk
regarding the investigational device. These studies are still subject to
abbreviated federal IDE regulations. The Regulatory Affairs Unit will be
responsible for maintaining the sponsor records and informing investigators
of their regulatory responsibilities.
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Significant Risk Device Investigations-
These investigations are conducted under an FDA Investigational Device
Exemption (IDE) for which an application and full submission to the federal
agency is required. This submission will be completed by the Regulatory
Affairs Unit in conjunction with other units of the RSC and the
investigator. Following approval, the sponsor records will be maintained by
the Regulatory Affairs Unit. They will also be responsible for informing
investigators of their responsibilities.
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Premarket Notification (510K) or Premarket Application (PMA)-
The Regulatory Affairs Unit will serve as the coordinator of any submission
in support of a 510K or PMA to the FDA. These are the two methods of
obtaining clearance (510K) or approval (PMA) for a medical device to be
marketed.
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