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Risk Evaluation and Mitigation Strategies (REMS) is a program of the US Food and Drug Administration for the monitoring of medications with a high potential for serious adverse effects. REMS applies only to specific prescription drugs, but can apply to brand name or generic drugs. [1] The REMS program was formalized in 2007.
Conformance testing — an element of conformity assessment, and also known as compliance testing, or type testing — is testing or other activities that determine whether a process, product, or service complies with the requirements of a specification, technical standard, contract, or regulation.
Once a doctor decides a patient is a candidate for isotretinoin, [10] they counsel the patient to ensure they understand the drug and the potential side effects. Once the patient signs the necessary paperwork, their doctor will give them a patient ID number, ID card, and program educational materials.
Common technical document summaries. Quality. Nonclinical study reports. Clinical study reports; A full table of contents could be quite large. There are two categories of modules: Regional module: 1 (different for each region; i.e., country) Common modules: 2–5 (common to all the regions) The CTD defines the content only of the common modules.
Historically, most classes of technical documentation lacked universal conformity for format, content and structure. Standards are being developed to redress this through bodies such as the International Organization for Standardization(ISO), which has published standards relating to rules for preparation of user guides, manuals, product specifications, etc. for technical product documentation.
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A technical standard is an established norm or requirement for a repeatable technical task which is applied to a common and repeated use of rules, conditions, guidelines or characteristics for products or related processes and production methods, and related management systems practices. A technical standard includes definition of terms ...
The standard provides with the document kind classification code (DCC) a structured letter-code for the classification of any kind of document. A public access database IEC 61355 DB [ 3 ] is available in order to facilitate the individuation of the correct code to be applied to a document