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In the 1980s, the European Union began harmonising regulatory requirements. In 1989, Europe, Japan, and the United States began creating plans for harmonisation. The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) was created in April 1990 at a meeting in Brussels.
However, work stalled on the project. An additional Draft Implementation Guide was released in February 2015 [5] The ICH and the FDA released draft specifications and guides in April 2016, and on May 13 there was an ICH "teleconference" to discuss the guidance and any queries or clarifications that might be necessary. [6]
Universal numbering system. This is a dental practitioner view, so tooth number 1, the rear upper tooth on the patient's right, appears on the left of the chart. The Universal Numbering System, sometimes called the "American System", is a dental notation system commonly used in the United States. [1] [2]
Good documentation practice (recommended to abbreviate as GDocP to distinguish from "good distribution practice" also abbreviated GDP) is a term in the pharmaceutical and medical device industries to describe standards by which documents are created and maintained.
The use of high-quality research to establish the guidelines for best practices defines evidence-based practice. In essence, evidence-based dentistry requires clinicians to remain constantly updated on current techniques and procedures so that patients can continuously receive the best treatment possible.
Dental implants [3] is one of the most advanced dental technologies in the field of dentistry. Certification in the dental laboratory profession is strictly voluntary. Laboratories who have taken the extra steps to become certified represent the top of their field. The most easily obtainable certification is the CDL (Certified Dental Laboratory).
In the United States, DMFs are submitted to the Food and Drug Administration (FDA). The Main Objective of the DMF is to support regulatory requirements and to prove the quality, safety and efficacy of the medicinal product for obtaining an Investigational New Drug Application (IND), a New Drug Application (NDA),As an Abbreviated New Drug Application (ANDA), another DMF, or an Export Application.
The dental dam is prepared by punching one or more holes in the dental dam sheet to enable isolation of the appropriate number of teeth required for the dental procedure. The dental dam is then applied to the tooth, anchored into place using a metal or flexible plastic clamp (chosen according to the tooth and area it will be applied to).