Crowns may be temporary or permanent and may be made out of materials such as porcelain, resin, or metal. Dentures Dentures, removable replacements for missing teeth, come in two types: partial and complete dentures. Dental implants and bridges are suitable alternatives to dentures.
Investigational Drugs and Devices (IND/IDE) Overview. As defined by the Food and Drug Administration (FDA), an IND, or investigational new drug application, is a request for authorization from the FDA to administer an investigational drug or biological product to humans.
Designating an Orphan Product: Drugs and Biological Products. The Orphan Drug Act (ODA) provides for granting special status to a drug or biological product (âdrugâ) to treat a rare disease or condition upon request of a sponsor. This status is referred to as orphan designation (or sometimes âorphan statusâ).