- Industry: Government
- Number of terms: 2516
- Number of blossaries: 0
- Company Profile:
The FDA is responsible for pprotecting the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products, medical devices, the US food supply, cosmetics, dietary supplements, and products that give off radiation.
The FDA approved label is the official description of a drug product which includes indication (what the drug is used for); who should take it; adverse events (side effects); instructions for uses in pregnancy, children, and other populations; and safety information for the patient. Labels are often found inside drug product packaging.
Industry:Pharmaceutical
Marketing status indicates how a drug product is sold in the United States. Drug products in Drugs@FDA are identified as:
* Prescription
* Over-the-counter
* Discontinued
* None - drug products that have been tentatively approved
Industry:Pharmaceutical
A medication guide contains information for patients on how to safely use a drug product.
Industry:Pharmaceutical
When the sponsor of a new drug believes that enough evidence on the drug's safety and effectiveness has been obtained to meet FDA's requirements for marketing approval, the sponsor submits to FDA a new drug application (NDA). The application must contain data from specific technical viewpoints for review, including chemistry, pharmacology, medical, biopharmaceutics, and statistics. If the NDA is approved, the product may be marketed in the United States. For internal tracking purposes, all NDA's are assigned an NDA number.
Industry:Pharmaceutical
This six digit number is assigned by FDA staff to each application for approval to market a new drug in the United States. A drug can have more than one application number if it has different dosage forms or routes of administration. In Drugs@FDA, you can find the NDA number under the column named "FDA Application."
Industry:Pharmaceutical
A New Molecular Entity is an active ingredient that has never before been marketed in the United States in any form.
Industry:Pharmaceutical
FDA defines OTC drugs as safe and effective for use by the general public without a doctor's prescription.
Industry:Pharmaceutical
A patient package insert contains information for patients' understanding of how to safely use a drug product.
Industry:Pharmaceutical
FDA considers drug products to be pharmaceutical equivalents if they meet these three criteria:
* they contain the same active ingredient(s)
* they are of the same dosage form and route of administration
* they are identical in strength or concentration
Pharmaceutically equivalent drug products may differ in characteristics such as
* shape
* release mechanism
* labeling (to some extent)
* scoring
* excipients (including colors, flavors, preservatives)
Industry:Pharmaceutical
A prescription drug product requires a doctor's authorization to purchase.
Industry:Pharmaceutical
