Regulatory approval

S. E. Builder, R. van Reis, N. Paoni, and J. Ogez, "Process Development and Regulatory Approval of Tissue-Type Plasminogen Activator," in... 

Sucrose polyesters, which are made by esterilying sucrose with long-chain fatty acids, have the physical properties of fat, but are resistant to digestive enzymes (40). Olestra, a sucrose polyester developed by Procter Gamble, was submitted for regulatory approval in May 1987. In order to faciUtate the approval process, Procter Gamble has since narrowed the scope of its food additive petition to include olestra s use only in savory and extmded snacks. 

Many companies have received patents for development of fat substitutes (Table 4) but few have demonstrated strong intentions to move toward regulatory approval. 

New dmg apphcation (NDA) is the process through which the U.S. Food and Dmg Administration (FDA) authorizes the marketing of a new dmg. In the NDA, the data are intended to demonstrate the safety and efficacy of the dmg in its intended apphcation. After approval, the dmg becomes available to the pubhc. Subsequendy, dosage amounts and forms may be modified according to experience, new indications may be added, and contraindications may be noted. All of the changes requite regulatory approval. A dmg in human use is subject to constant surveillance. 

However, clinical results with compounds enhancing cholinergic function have not been overly convincing (272). In the case of tacriae, however, the beneficial therapeutic iadex was sufficient to justify regulatory approval ia several countries. Psychostimulants such as pemoline, amphetamine, procaine, and methylphenidate have failed to show cognitive enhancing effects ia patients with dementia, except possibly as iadirect consequences of mood elevation. 

PET imaging systems are somewhat more complex, and therefore more expensive than are SPECT systems, and the price factor is generally between two and three. The primary cost premium associated with these systems, however, is the need for a cyclotron and its attendant staff combined with the relative complexity of radiopharmaceutical preparation for short half-life isotopes. As of 1996, there are considerable hurdles blocking widespread regulatory approval and full reimbursement of PET studies. 

The exact requirements for regulatory approval of a given product for veterinary purposes, whether prescription or over-the-counter, vary from country to country. Product development often takes a minimum of eight to ten years and usually requires large (> 10 x 10 ) sums of money. 

The use of recombinant hematopoietic growth factors (i.e., the commercially available forms of the native products) has been evaluated in many disorders affecting all types of blood cells. Recombinant human hematopoietic growth factors are identified as rHu. Not all uses discussed have received regulatory approval in all countries. 

The requirements for regulatory approval and intellectual property management, and in particular the ability to file USPTO patent submissions, do place constraints on what systems can be applied for record keeping, but the good news is that there are no insurmountable barriers to these records being captured and managed electronically. 

Regulatory approval Several EPA methods None at present... 

Contracting out of activities previously only conducted in-house is already becoming quite common and will probably continue to develop. In the past a so-called full-service pharmaceutical company took direct responsibility for all the activities required for the formulation, manufacture, quality control, and regulatory approval of its drug products. Nowadays the use of specialist contract houses to perform activities such as formulation, analytical methods development, manufacture of clinical trials supplies, supervision of the assembly of an NDA, postmarketing surveillance, and even troubleshooting may be contracted for even by some of the largest companies. 

Regulatory status In 1998, Lopez Canyon Sanitary Landfill received conditional approval for an ET cover, which required a minimum of 2 years of field performance data to validate the model used for the design. An analysis was conducted and provided the basis for final regulatory approval of the ET cover. The cover was fully approved in October 2002 by the California Regional Water Quality Control Board—Los Angeles Region. 

It can be concluded that these models yield a satisfactory picture of the behavior and persistence of this PCB. The dominant processes are apparent. A new chemical of similar properties is unlikely to receive environmental regulatory approval, thus the model is apparently capable of identifying such chemicals prior to their dispersal into the environment. 

In fact, one metal complex has already had considerable clinical application in PDT, although its regulatory approval status is not clear at present. The photosensitizer has the trade name PHOTOSENS and may be represented by structure (7). It is prepared by the direct sulfonation of chloroaluminum(III)-phthalocyanine, and the isolated material appears to contain a mixture of... 

The pharmaceutical industry anticipates that molecular farming will save time and money compared to traditional production systems. Because of bottlenecks and production costs, many biologies will never reach the market and the intended patients, or will do so only with great delays, if molecular farming fails. However, a number of points in the production of plant-derived proteins have yet to be addressed appropriately. In order to fulfill all requirements and obtain regulatory approval, the questions outlined above have to be answered for each recombinant protein. Last but not least, economical factors will decide whether molecular farming in plants will increase the number of available products. 

IFN-a2b is now approved in the USA for the treatment of hepatitis B and C. Clinical studies undertaken with additional IFN-a preparations indicate their effectiveness in managing such conditions, and several such products are also likely to gain regulatory approval. 

Several CSF preparations have gained regulatory approval (Table 10.2). G-CSF and GM-CSF have proven useful in the treatment of neutropenia. All three CSF types are (or are likely to be) useful also in the treatment of infectious diseases, some forms of cancer and the management of bone marrow transplants, as they stimulate the differentiation/activation of white blood cell types most affected by such conditions. 

Figure 12.12 Production of Ecokinase, a modified tPA molecule that gained regulatory approval in Europe in 1996. The production cell line is recombinant E. coli K12, which harbours a nucleotide sequence coding for the shortened tPA molecule. The product accumulates intracellularly in the form of inclusion bodies...

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