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.
When reviewing an original IND submission or planning for a pre-IND meeting, the FDA. review teamâs primary concern is the safety of the subjects who will receive the drug. during the proposed clinical trial. A secondary consideration is evaluation of the initial.