Regulatory Terms Starting With S

9 terms in the S index.

• SAE (Serious Adverse Event)

  An SAE is any adverse event or suspected adverse reaction that results in death, a life-threatening event, inpatient hospitalization or its prolongation, persistent or significant incapacity, or a congenital anomaly, in the view of either the investigator or sponsor.

• Signal Detection

  Signal detection is the pharmacovigilance activity of searching safety data for evidence that a medicine may cause a new adverse reaction, or that a known reaction has changed, before that evidence is confirmed.

• Signal Management (Signal Management)

  Signal management is the pharmacovigilance process that carries a suspected safety issue from detection through validation, confirmation, prioritisation and assessment to a documented regulatory decision, with every step, date and rationale tracked.

• Special 510(k)

  A Special 510(k) is the streamlined premarket notification format for a change the submitter makes to its own previously cleared device, where design control activities can verify and validate the change against well-established methods.

• Stability Testing (Stability)

  Stability testing is the formal study program that measures how a drug substance or product changes under defined temperature, humidity, and light conditions, generating the evidence that sets shelf life, storage conditions, and the expiration date on the label.

• Substantial Equivalence (SE)

  Substantial equivalence is the FDA finding that a device has the same intended use as a legally marketed predicate and either the same technological characteristics or different ones that raise no new questions of safety and effectiveness.

• Supplier Qualification

  Supplier qualification is the documented assessment that establishes a supplier's ability to consistently provide materials or services meeting specification, and the ongoing verification that keeps that conclusion current.

• SUSAR (Suspected Unexpected Serious Adverse Reaction)

  SUSAR is a serious adverse reaction observed in a clinical trial that is both suspected to be caused by the investigational drug and not already described in the current investigator brochure, triggering expedited regulatory reporting.

• Swissmedic

  Swissmedic is the Swiss Agency for Therapeutic Products, the federal public law institution that authorises and supervises medicines and medical devices in Switzerland under the Therapeutic Products Act.