D	C96069	Stability Data Standards Terminology	C96071	Stability Study Data File Reason Terminology	Terminology developed to support Data File Reasons within the Stability Data Standards.	Stability Study Data File Reason Terminology	This code should indicate the type of application the data supports or whether the data is submitted to an existing application. The codes indicate that the data is part of an Annual Report, New Drug Application, New Active Ingredient, Biologics License Application, Premarket Approval, or Supplement to an Approved Application.
D	C96071	Stability Study Data File Reason Terminology	C115122	Generic Investigational New Animal Drug File	Data submitted to a generic investigational new animal drug file.	Generic Investigational New Animal Drug File	Stability data submitted to a generic investigational new animal drug file.
D	C96071	Stability Study Data File Reason Terminology	C115123	Abbreviated New Animal Drug Application	Data submitted to an abbreviated new animal drug application.	Abbreviated New Animal Drug Application	Stability data submitted to an abbreviated (generic) new animal drug application.
D	C96071	Stability Study Data File Reason Terminology	C70880	Premarket Approval Application		Premarket Approval	Stability data submitted for a PMA application.
D	C96071	Stability Study Data File Reason Terminology	C71778	Biologics License Application	A formal submission to FDA from any legal person or entity to obtain permission for manufacturing and marketing a biological product subject to licensure under section 351 of the Public Health Service Act. A biologics license application must contains specific information on the manufacturing processes, chemistry, pharmacology, clinical pharmacology and the medical affects of the biologic product, sufficient for the FDA to determine that the establishment and the product meet applicable requirements to ensure the continued safety, purity, and potency of the product, including but not limited to GMPs.	Biologics License Application	Stability data submitted to a biologics license application.
D	C96071	Stability Study Data File Reason Terminology	C72899	New Drug Application	A regulatory document submitted to the FDA proposing the approval of a new drug to be marketed and sold in the U.S. It includes supporting data from both animal and human studies that was initially provided in the Investigational New Drug application (IND).	New Drug Application	Stability data submitted to a new human drug application.
D	C96071	Stability Study Data File Reason Terminology	C72901	New Animal Drug Application		New Animal Drug Application	Stability data submitted to a new animal drug application.
D	C96071	Stability Study Data File Reason Terminology	C73113	Abbreviated New Drug Application	Data submitted to an abbreviated new drug application.	Abbreviated New Drug Application	Stability data submitted to an abbreviated (generic) new human drug application.
D	C96071	Stability Study Data File Reason Terminology	C80440	Humanitarian Device Exemption	A premarket submission to FDA for a device intended to benefit patients by treating or diagnosing a condition affecting fewer than 4,000 individuals in the United States per year. An HDE is similar in form and content to a premarket approval (PMA) but is exempt from the effectiveness requirements of a PMA.	Humanitarian Device Exemption (HDE)	Stability data submitted for an HDE application.
D	C96071	Stability Study Data File Reason Terminology	C80442	Premarket Device Notification	A premarket submission made to FDA to demonstrate that a device to be marketed is at least as safe and effective as a legally marketed device that is not subject to PMA (Premarket Authorization).	Premarket Notification 510(K)	Stability data submitted for a premarket 510(k) submission.
D	C96071	Stability Study Data File Reason Terminology	C82667	Investigational Device Exemption	Allows an investigational device to be used in a clinical study in order to collect safety and effectiveness data required to support a Premarket Approval application or a Premarket Notification submission to the Food and Drug Administration.	Investigational Device Exemption	Stability data submitted to an investigational device exemption.
D	C96071	Stability Study Data File Reason Terminology	C96089	Annual Report		Annual Report	Stability data submitted to an annual report or update to an approved application.
D	C96071	Stability Study Data File Reason Terminology	C96090	Investigational New Drug Application		Investigational New Drug Application	Stability data submitted to an investigational new human drug application.
D	C96071	Stability Study Data File Reason Terminology	C96091	Investigational New Animal Drug File		Investigational New Animal Drug File	Stability data submitted to an investigational new animal drug file.
D	C96071	Stability Study Data File Reason Terminology	C96092	New Active Ingredient		New Active Ingredient	Stability data submitted for an active ingredient, could be stability data for an active ingredient submitted in a drug application, or a Master File.
D	C96071	Stability Study Data File Reason Terminology	C96094	Approved Application Supplement		Supplement to an Approved Application	Stability data submitted to an approved application already filed with the FDA.
C	C96083	Stability Study Pause Description Terminology	C96150	Immediate Testing	Sample is tested immediately.	Immediate	Sample is tested immediately.
C	C96083	Stability Study Pause Description Terminology	C96151	Delayed Testing	Sample is not tested immediately.	Delayed	Sample is not tested immediately.
C	C96083	Stability Study Pause Description Terminology	C96153	Frozen Delayed Testing	Sample is frozen and not tested immediately.	Delayed, Frozen	Sample is frozen and not tested immediately.
C	C96083	Stability Study Pause Description Terminology	C96154	Ambient Delayed Testing	Sample is stored at ambient conditions and not tested immediately.	Delayed, Ambient	Sample is stored at ambient conditions and not tested immediately.
C	C96083	Stability Study Pause Description Terminology	C96155	Refrigerated Delayed Testing	Sample is refrigerated and not tested immediately.	Delayed, Refrigerate	Sample is refrigerated and not tested immediately.