Regulatory Terms Starting With I

11 terms in the I index.

• ICH (International Council for Harmonisation)

  ICH is the global standards body where pharmaceutical regulators and industry associations jointly draft technical guidelines for drug quality, safety, and efficacy; it enacts no law itself, so guidelines apply only once a member authority adopts them.

• ICH M7 (ICH M7)

  ICH M7 is the harmonised guideline governing assessment and control of DNA reactive (mutagenic) impurities in pharmaceuticals, setting acceptable intake limits that ICH Q3A and Q3B leave undefined for genotoxic impurities.

• IEC 62304 (IEC 62304)

  IEC 62304 is the international standard defining the life cycle processes for medical device software, covering development and maintenance of software that is itself a device or embedded in one, but stopping short of final device validation and release.

• IND (Investigational New Drug)

  IND is the FDA application a sponsor submits before shipping or administering an unapproved drug to human subjects, authorizing a clinical investigation rather than granting marketing approval. Studies of a lawfully marketed drug may be exempt.

• IND-Enabling Studies (IND-Enabling)

  IND-enabling studies are the nonclinical pharmacology, toxicology and ADME work a sponsor runs to support the conclusion that human dosing is reasonably safe, distinguishing them from exploratory discovery studies never submitted to FDA.

• Informed Consent (ICF)

  Informed Consent is the legally effective authorization a research subject gives before any study procedure, obtained under conditions that allow unhurried consideration, minimize coercion, and use language the subject actually understands.

• Investigational Device Exemption (IDE)

  Investigational Device Exemption is FDA authorization to ship and use an uncleared or unapproved device in a clinical investigation, exempting it from premarket approval and performance-standard requirements while safety and effectiveness data is collected.

• Investigator's Brochure (IB)

  The Investigator's Brochure is the sponsor-maintained compilation of clinical and nonclinical data on an investigational product, functioning as its pre-approval labeling: the reference investigators use to judge risk-benefit and comply with the protocol.

• IRB (Institutional Review Board)

  An IRB is the committee a research institution formally designates to approve, require modification of, or disapprove human-subject research before it begins, and to re-review it at least annually under FDA rules.

• ISO 14971 (ISO 14971)

  ISO 14971 is the international consensus standard for applying risk management to medical devices, covering the identification, evaluation, and control of risk to patients and users across the product lifecycle rather than at a single design stage.

• IVD (In Vitro Diagnostic)

  IVDs are reagents, instruments, and systems intended for use in diagnosing disease or other conditions, including determining a state of health. They are regulated as medical devices but act on specimens taken from the body, not the patient.