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Introduction
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What FDA Regulates
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Clarifying the "new" in IND
Assessing Preclinical Data
Properties of the Study Drug
How the Data is Used
IND Submission
IND Holder Reponsibilities

3 Types of Authorities Empowered to FDA

1. Procedural Law

This refers to the process by which the FDA “makes rules” by soliciting and incorporating public comments.

The process involves:

  1. Publishing draft versions of all regulatory and guidance document development
  2. Soliciting comments from the public on these draft versions
  3. Reviewing, assessing and publishing comments
  4. Finalization of ruling/guidance

The current list of FDA dockets awaiting comments can be found at:
http://www.fda.gov/ohrms/dockets/DOCKETSCLOSE/Commentsdue.htm

2. Interpretive Law

This facet of FDA authority is represented primarily through the development and publishing of Guidance Documents. Guidance documents are generally provided as “advice”, or methods by which the regulations can be met. Although they are technically “guidance” and not law, they are used by the courts to interpret the law. FDA’s position on the use of guidance is that a researcher is free to use other means to fulfill the requirements of the law if they have an equal or better process than that which is detailed in the Guidance documents.

3. Substantive Law

This is the “rule-making”. Title 21 of the CFR is considered “rules” or regulation. Regulation has all the force of law.

The FDA is empowered with judicial, legislative, and executive authority. This means that the FDA writes regulations with the force of law, judges whether the law has been followed, and assigns penalties based on their assessment of the severity of the infraction. Violation of FDA regulation can be considered a criminal offense.