Which types of adverse events must be reported to the FDA?
The event is serious and should be reported to FDA when the patient outcome is:
- Hospitalization (initial or prolonged)
- Disability or Permanent Damage.
- Congenital Anomaly/Birth Defect.
- Required Intervention to Prevent Permanent Impairment or Damage (Devices)
- Other Serious (Important Medical Events)
What are the FDA criteria for therapeutic equivalence?
FDA classifies as therapeutically equivalent those drug products that meet the following general criteria: (1) they are approved as safe and effective; (2) they are pharmaceutical equivalents in that they (a)contain identical amounts of the identical active drug ingredient in the identical dosage form and route of …
Do excipients need FDA approval?
Under U.S. law, an excipient, unlike an active drug substance, has no regulatory status and may not be sold for use in food or approved drugs unless it can be qualified through one or more of the three U.S. Food and Drug Administration (FDA) approval mechanisms that are available for components used in food and/or …
What is adverse event data?
The Adverse Event Reporting System (AERS) is a computerized information database designed to support the Food and Drug Administration’s (FDA) post-marketing safety surveillance program for all approved drug and therapeutic biologic products.
How are adverse events reported to FDA?
Use one of the methods below to submit voluntary adverse event reports to the FDA:
- Report Online.
- Consumer Reporting Form FDA 3500B.
- Call FDA at 1-800-FDA-1088 to report by telephone.
- Reporting Form FDA 3500 commonly used by health professionals.
Which structurally different drugs give same clinical result it is called?
A. Therapeutic equivalence.
What is novel excipient?
ICH, EMA: A novel excipient is an excipient which is being used for the first time in a drug product, or by a new route of administration. It may be a new chemical entity or a well-established one which has not yet been used for human administration and /or for a particular human administration pathway.
What are functional excipients?
The term ‘high functionality excipients’ refers to a single excipient that provides additional functions to innovative drug delivery systems to improve the overall performance of the product with significant economic benefits.
What is an adverse event in healthcare?
Listen to pronunciation. (AD-vers eh-VENT) An unexpected medical problem that happens during treatment with a drug or other therapy. Adverse events may be mild, moderate, or severe, and may be caused by something other than the drug or therapy being given.
How do you classify adverse events?
Adverse events are classified by each investigator using three criteria in specific order: seriousness, expectedness and relatedness to the investigational intervention. Once classified, events are entered into an online database that includes collation, retrieval and search capabilities.