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.
The following summary includes. exemptions based on the IND Regulations, determinations from the 2013 FDA IND. Exemption Guidance and examples from the 2004 FDA Guidance on IND exemptions. for cancer treatment studies.