The following are standard ADR frequency categories where the denominator must be defined to provide context: Very common: > 10% Common: [1%, 10%] Uncommon: [0.1%, 1%] Rare:

The Food and Drug Administration is responsible for protecting the public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological

An identifier chosen from a defined list that is applied to an element in a Study Tagging File that identifies the type of the file.

FDA form: Application to Market a New or Abbreviated New Drug or Biologic for Human Use

FDA Transmittal of Advertisements and Promotional Labeling for Drugs and Biologics for Human Use form submitted to the FDA with all promotional material sequences.

FDA Statement of Investigator form.

FDA Investigational New Drug application form. The cover sheet for a US Investigational New Drug (IND) Application, which reports the phase of a proposed study,

The HL7® FHIR® (Fast Healthcare Interoperability Resources 1 ) standard defines how healthcare information can be exchanged between different computer systems regardless of how it