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EMA/129698/2012: Concept paper on extrapolation of efficacy and safety in medicine development. [10] FDA-2015-D-1376: Leveraging existing clinical data for extrapolation to pediatric uses of medical devices. Guidance for Industry and Food and Drug Administration Staff. [11] ICH E5 (R1): Ethnic factors in the acceptability of foreign clinical ...
[11] [12] [13] Variant interpretation and classification is notably subjective, as laboratories developed their own criteria prior to the ACMG-AMP guidelines. [ 8 ] [ 9 ] [ 14 ] This subjectiveness is further problematic when there is evidence that variant significance changes over time. [ 13 ]
The European Medicines Agency (EMA) operates as a decentralised scientific agency (as opposed to a regulatory authority) of the European Union (EU) and its main responsibility is the protection and promotion of public and animal health, through the evaluation and supervision of medicines for human and veterinary use. [8]
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]
The Biopharmaceutics Classification System: Highlights of the FDA's Draft Guidance Office of Pharmaceutical Science, Center for Drug Evaluation and Research, Food and Drug Administration. Mills D (2005). Regulatory Agencies Do Not Require Clinical Trials To Be Expensive International Biopharmaceutical Association: IBPA Publications.
The Certification procedure [17] is not compulsory: it is a service that is offered to manufacturers who can submit their CEP [18] in the quality section of a new marketing authorisation (MA) application or a variation of an existing MA. It serves to centralise the evaluation of data for the benefit of both regulatory authorities and industry ...
Drug nomenclature is the systematic naming of drugs, especially pharmaceutical drugs.In the majority of circumstances, drugs have 3 types of names: chemical names, the most important of which is the IUPAC name; generic or nonproprietary names, the most important of which are international nonproprietary names (INNs); and trade names, which are brand names. [1]
The WHODrug Dictionary is an international classification of medicines created by the WHO Programme for International Drug Monitoring and managed by the Uppsala Monitoring Centre. [ 1 ] It is used by pharmaceutical companies , clinical trial organizations and drug regulatory authorities for identifying drug names in spontaneous ADR reporting ...