Deleted	C133847	PQ/CMC Chemical Structure Data File Origin Terminology	C133995	Experimentally Determined Chemical Structure	Chemical structure derived from an investigative process using instrumentation.	Experimental		Chemical structure derived from an investigative process using instrumentation.
Deleted	C133847	PQ/CMC Chemical Structure Data File Origin Terminology	C16275	Algorithm	A defined procedure for solving a problem. Applied to a problem-solving procedure implemented in software to be executed by a computer.	Calculated		A defined procedure for solving a problem. Applied to a problem-solving procedure implemented in software to be executed by a computer.
New	C133848	PQ/CMC Chemical Structure Data File Type Terminology	C133910	MOLFILE		
New	C133848	PQ/CMC Chemical Structure Data File Type Terminology	C133996	SDF		
New	C133848	PQ/CMC Chemical Structure Data File Type Terminology	C133997	mmCIF (large molecules)
New	C133848	PQ/CMC Chemical Structure Data File Type Terminology	C49039	PDB
New	C133848	PQ/CMC Chemical Structure Data File Type Terminology	C54683	InChI File (small molecule)
New	C133848	PQ/CMC Chemical Structure Data File Type Terminology	C54684	SMILES
Deleted	C96071	PQ/CMC Stability Study 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		PQCMC data submitted to a generic investigational new animal drug file.
Deleted	C96071	PQ/CMC Stability Study Reason Terminology	C115123	Abbreviated New Animal Drug Application	Data submitted to an abbreviated new animal drug application.	Abbreviated New Animal Drug Application		PQCMC data submitted to an abbreviated (generic) new animal drug application.
Deleted	C96071	PQ/CMC Stability Study Reason Terminology	C70877	Drug Master File	Drug Master File (DMF) is a submission to the Food and Drug Administration (FDA) that may be used to provide confidential detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of one or more human drugs.	Master File		Drug master files (DMFs) are submissions to FDA used to provide confidential, detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of human drug products. They 1) Allow parties to reference material without disclosing DMF contents to those parties. 2) Are not required by statute or regulation. 3) Are neither approved nor disapproved. Instead, FDA reviews the technical contents of DMFs in connection with the review of applications that reference them (e.g., NDAs, ANDAs, INDs, BLAs).
Deleted	C96071	PQ/CMC Stability Study Reason Terminology	C70880	Pre-market Approval Application	An application to FDA for a license to market a new device in the United States.	Premarket Approval		PQCMC data submitted for a PMA application.
Deleted	C96071	PQ/CMC Stability Study 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		PQCMC data submitted to a biologics license application.
Deleted	C96071	PQ/CMC Stability Study 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		PQCMC data submitted to a new human drug application.
Deleted	C96071	PQ/CMC Stability Study Reason Terminology	C72901	New Animal Drug Application	Data submitted to a new animal drug application.	New Animal Drug Application		PQCMC data submitted to a new animal drug application.
Deleted	C96071	PQ/CMC Stability Study Reason Terminology	C73113	Abbreviated New Drug Application	Data submitted to an abbreviated new drug application.	Abbreviated New Drug Application		PQCMC data submitted to an abbreviated (generic) new human drug application.
Deleted	C96071	PQ/CMC Stability Study 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)		PQCMC data submitted for an HDE application.
Deleted	C96071	PQ/CMC Stability Study 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)		PQCMC data submitted for a premarket 510(k) submission.
Deleted	C96071	PQ/CMC Stability Study 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		PQCMC data submitted to an investigational device exemption.
Deleted	C96071	PQ/CMC Stability Study Reason Terminology	C96089	Annual Report		Annual Report		PQCMC data submitted to an annual report or update to an approved application.
Deleted	C96071	PQ/CMC Stability Study Reason Terminology	C96090	Investigational New Drug Application	Data submitted to an investigational new human drug application.	Investigational New Drug Application		PQCMC data submitted to an investigational new human drug application.
Deleted	C96071	PQ/CMC Stability Study Reason Terminology	C96091	Investigational New Animal Drug File	Data submitted to an investigational new animal drug file.	Investigational New Animal Drug File		PQCMC data submitted to an investigational new animal drug file.
Deleted	C96071	PQ/CMC Stability Study Reason Terminology	C96092	New Active Ingredient	Data submitted for an active ingredient.	New Active Ingredient		PQCMC data submitted for an active ingredient, could be PQCMC data for an active ingredient submitted in a drug application, or a Master File.
Deleted	C96071	PQ/CMC Stability Study Reason Terminology	C96094	Approved Application Supplement		Supplement to an Approved Application		PQCMC data submitted to an approved application already filed with the FDA.