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.
â¢ The requirements for submission of a Bio-IND in support of an abbreviated new drug application (ANDA) were revised when FDA published the Title I regulations in April of 1992. As stated in 21 CFR 320.31(a), any sponsor planning to conduct an in vivo bioavailability or bioequivalence study in humans should submit a Bio-IND if: (1) The study involves a radioactive labeled drug product, or (2) The study involves a cytotoxic drug.