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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]
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.
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.
By the late 1980s, BFS had been well-established in the packaging industry, especially for packaging pharmaceutical and healthcare products. [14] During the 1980s and 1990s, BFS came into use for the now common small volume unit-dosage forms. [12] Since the early 2000s, BFS has been emerging as the preferred packaging process for parenteral ...
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).
CAD/CAM Dentistry • Calcifying epithelial odontogenic tumor • Calcifying odontogenic cyst • Calcium hydroxide • Calculus • California Dental Association • Canadian Association of Orthodontists • Canadian College of Dental Health • Canadian Dental Association • Canalicular adenoma • Canine tooth • Cantilever mechanics • Carbon dioxide laser • Caries vaccine ...
Dental aerosol from a dental hand piece. A dental aerosol is an aerosol that is produced from dental instrument, dental handpieces, three-way syringes, and other high-speed instruments. These aerosols may remain suspended in the clinical environment. [1] Dental aerosols can pose risks to the clinician, staff, and other patients