Regulatory view

The regulatory position with regard to multiplicity is well expressed in ICH E9. 

ICH E9 (1998) Note for Guidance on Statistical Principles for Clinical Trials  

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From a regulatory view, there is no such thing as a natural color, although it is generally accepted that colorants exempt from certification are usually naturally derived. ... 

Poochikian, G. and Bertha, C.M., Regulatory view on current issues pertaining to inhalation drug products, Respiratory Drug Delivery VIII Conference, Vol. 1, 2000, pp. 159-164 [www.rddonline.com]. 

Kumi KI, Booth BP. A regulatory view of liposomal drug product characterization. New Drug Development. Marcel Dekker, Inc., 2004. 

E. R. Sheinin, Trends in the HPLC analysis of marketed pharmaceuticals a regulatory view. In Liquid Chromatography in Pharmaceutical Development (I. W. Wainer, ed.), Aster Publishing, Springfield, OR, 1985, p.444. 

Hung, H.M.J., O Neill, R.T., Wang, S-J., and Lawrence, J., 2006, A regulatory view on adaptive/flexible clinical trial design, Biometrical Journal, 48 565-573. 

A finished packaging material for a specific food, e.g. a roll of printed laminate film, often possesses a certain individual odor. Even though from a food regulatory view only the transfer of odor substances to the food is important and not the individ-... 

Multiplicity continues to be a field of much research and controversy. Good reviews are given by Cook and Farewell (1996), Koch and Gansky (1996), and Wassmer et fll. (1999) and a regulatory view by the Committee for Proprietary Medicinal Products (2002). 

Mathieu M. New Drug Development A Regulatory View. 5th ed. Waltham, MA Parexel, 2000. 

The operation of sociotechnical safety control structures at all levels is facing the stresses noted in chapter 1, such as rapidly changing technology, competitive and time-to-market pressures, and changing public and regulatory views of responsibility for safety. These pressures can lead to a need for new procedures or new controls to ensure that required safety constraints are not ignored. 

The recent withdrawal of cypermethrin-based sheep dips in the UK because of environmental contamination and potential adverse environmental effects serves as an example of what might happen - both from a scientific and regulatory view point.This is an increasingly important area of veterinary pharmacovigilance. 

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