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Proposed procedural changes in new drug evaluation by the Food and Drug Administration
Author(s) -
Walters Philip G.
Publication year - 1976
Publication title -
clinical pharmacology and therapeutics
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.941
H-Index - 188
eISSN - 1532-6535
pISSN - 0009-9236
DOI - 10.1002/cpt1976195part2700
Subject(s) - food and drug administration , new drug application , drug , medicine , declaration , declaration of helsinki , medical physics , medical education , risk analysis (engineering) , business , pharmacology , informed consent , alternative medicine , political science , law , pathology
Proposals for changes in the procedures for evaluating new drug applications by the Food and Drug Administration (FDA) are described. Under consideration are the following innovations. (1) The sponsor is to submit protocols at the time of applying for an 1ND and prior to initiating studies. Data are 10 be submitted at the end of each Phase (I, II, III) of investigation, rather than as now at the time offiling the New Drug Application (NDA). By this system it is hoped to identify early problems and to make recommendation to the sponsor for the next steps in the investigation. (2) To broaden the base on which the new drug is evaluated, it is proposed to make use of clinical data available from experts in other countries. Criteria of acceptability of evidential material from foreign clinical studies are essentially those that meet the standards imposed for United States investigations, e.g., training and experience qualifications of the investigator, adequacy offacilities for investigational studies, maintenance of detailed case reports, conduct of the studies in conformance with the declaration adopted by the World Medical Assembly (Helsinki 1964), and according to ethical considerations approved by a Review Committee.