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.
21 CFR 312.45 - Inactive status. Â§ 312.45 Inactive status. (a) If no subjects are entered into clinical studies for a period of 2 years or more under an IND, or if all investigations under an IND remain on clinical hold for 1 year or more, the IND may be placed by FDA on inactive status. This action may be taken by FDA either on request of the sponsor or on FDA's own initiative.