Permission marketing

What 1 love about Seth Godin is his blog, which is certainly easy to get lost in. Godin coined the term interruption marketing to describe tactics that work only if they interrupt you to get your attention. Instead, Godin promotes permission marketing, where a business provides relevant information to buyers. 

Technical data. The Pharmaceutical Market World Keview, Vol. I, International, IMS Global Services, 1994, used with permission C. Vezina, in Basic Biotechnology, J. Bu Lock and B. Kristiansen, eds.. Academic Press, Inc., New York, 1987, pp. 463—482. 

Requests for permission to conduct clinical trials with pharmaceuticals in the US are termed Investigational New Drug Applications (INDs). The applications are actually a request for an exemption to supply a drug without a marketing authorisation. A cover sheet (Form 1571) must accompany the application. This cover sheet should also be used with each subsequent communication with the FDA, with each form consecutively numbered, starting at 000 for the initial submission. A copy of the form is shovm in Figure 5.6. 

Figure 8. The gasoline marketing distribution system in the United States. (Reproduced with permission from Ref. 3.)...

COX-2 selectivity of marketed compounds. Adapted with permission from T.D. Warner et al. Proceedings of the National Academy of Sciences, 96, 13, 7563 (1999). Copyright 1999 National Academy of Sciences, U.S.A. 

Foreseen syngas market in 2040 compared with the current one, differentiated toward utilization. (Reproduced from Boerrigter, H., and van der Drift, A., Bio Key Intermediate in Production of Renewable Transportation Fuel, Chemicals and Electricity, Optimum and Economic Properties of Fischer-Tropsch Plants, ETA, 2005. Copyright by ECN. With permission.)... 

Figure 8.5 US and world markets for sol-gel products, 2006 and 2011. (Reproduced from ref. 1, with permission.)...

Persons and Activities Covered. TSCA 5 creates a premanufacture notification program, whereas the Sixth Amendment requires the submittal of premarket notifications. Thus, U.S. PMN s must be submitted no later than 90 days prior to the completion of R D activities, unless EPA grants permission to produce limited amounts for test marketing purposes. In contrast, companies in... 

In a nutshell, the law requires solid scientific evidence of safety and efficacy before a new drug will be permitted in clinical trials or (later) on the market. The INDA (covered in 21 CFR 310) is for permission to proceed with clinical trials on human subjects. Once clinical trials have been completed, the manufacturer or sponsor can then proceed to file an NDA (covered in 21 CFR 314) for permission to market the new drug. 

Permissible claims Must be generally Must be generally re- "Structure-function" claims "Structure-function" "Structure-function" Can be marketed... 

Figure 1.2 Number of chirai and achirai marketed NCEs. (Reprinted with permission from Farina, V., Reeves, J.T., Senanayake, C.H. and Song, j.j. Asymmetric synthesis of active pharmaceuticai ingredients. Chem. Rev. 2006, 106, 2734-2793. Copyright 2006, American Chemicai Society)...

A core activity of the CVMP is the establishment of MRLs of veterinary medicinal products permissible in food produced by or from animals for human consumption, including dairy products, meat, honey, etc. These limits must be established for all pharmacologically active substances contained in a medicinal product before the product can be granted a marketing authorization. 

All Rights Reserved. No part of this publication may be reproduced, stored in a retrieval system, or transmitted, in any form or by any means, electronic, mechanical, photocopying, recording or otherwise, without the permission of Ellis Horwood Limited, Market Cross House, Cooper Street, Chichester, West Sussex, England. 

Market research is mentioned here only to point out that such activity is permissible, must follow certain guidelines and may not be disguised promotion. Indeed, promotional activities of all types may not be disguised as to their true intent. 

As has already been stated, major new drugs intended for long-term use in common conditions may have been tested in several thousand patients by the time marketing permission... 

The FDA regulations or guidelines prescribe the types of safety tests for a particular product. Sponsors may conduct the studies in their own laboratories or have them performed by a contract laboratory, a university, or some other type of laboratory. The sponsor submits the study reports to the FDA in food and color additive petitions, investigational new drug applications, new drug applications, new animal drug applications, biological product license applications, and other requests for permission to market a product. 

J.Nystrom, A.D.LMe reproduced with permission of Bio/Technology, Nature America Inc.), emphasises the strong correlation between the crude product concentration and the product s production costs, over a broad range of products. Some biotech products now on the market he beyond the range of products previously being sold, commanding market prices 100-1,000-fold higher than predicted. 

Figure 13.15 The history of the cost of penicillins. How technical advances can reduce the price of chemicals and so move them from specialities into bulk markets. From King, P.P. (1982) Biotechnology—an industrial view. J. Chem. Technol. BiotechnoL, 32, 2-8. Reproduced with kind permission from Society of Chemical Industry, UK.

I. Data required to be submitted with application for permission to market a new drug. 

It is noted in the Executive Summary to the FDA study that the impacts given in the above paragraph do not take account of the possible "mitigating effects" of the May 17, 1978, version of the DRRA, such as the provision that the data cannot for a period of five years be used to obtain market approval for a drug product without the permission of the individual or entity that submitted the data originally. On the other side of the coin, however, is the fact that if one does not accept some or all of the assumptions of the FDA study, the sales loss, and in turn the loss in R D funds, could be significantly greater. 

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