New product approvals

In a recently completed study, DiMasi et al. have examined the average R D cost for drugs introduced into the market in the late 1990s. Data were collected on R D costs for a randomly selected sample of 68 investigational drugs from 10 multinational firms. DiMasi et al. found that the representative new product approval incurred out-of-pocket costs of over 400 million. This includes money spent in the discovery, preclinical, and clinical phases as well as an allocation for the cost of failures. 

The process validation protocol of a new aerosol product should be written by a qualified manufacturing or validation specialist familiar with aerosols. Others experienced in oral dosage forms such as suspensions or solutions would also be helpful. These technical specialists may be within the research, validation, or technical support departments, since this work will be done prior to approval of a new product. Approval of the protocol should be given by quality assurance, quality control, production management, and research. 

To conduct clinical research that meets the requirements of the FDA for new product approval, it is essential to understand these regulations and their subsequent impact on the clinical development process of drugs, devices, and biologies. 

Biotechnology has become a major and common platform for new products approved for clinical use. For example, from 1998 to 2003, biotech research and development was responsible for 36% of all new molecular entities and all drug approvals by the Food and Drug Administration in U.S.A. About 140 biological products are approved for use in U.S.A. for over 100 indications. ... 

All these regulatory innovations have improved labeling for clinicians using drugs for children, and have increased the frequency of pediatric clinical trials manyfold. By January 1, 2006, some 720 pediatric clinical trials had been specifically requested by FDA in connexion with new product approvals, and of these 35% have been for efficacy and safety, 29% for pharmacokinetics and safety, 15% solely for safety, 9% for PK-PD assessments and 12% for various others. These trials were reckoned to be in children with 117 different diseases, distributed among 15 specific therapeutic areas. 

HIPAA requirements for subject privacy is increasing the amount of documentation needed for the initiation of a trial. Besides the requirement for informed consent, which has evolved from the Declaration of Helsinki, there is now an additional need for authorization from the subject for release of the individually identifiable health information that the drug sponsor must enter into the data bank for statistical analysis to comply with requirements necessary for new product approvals. However, HIPAA does not include data needed for adverse experience reporting assessments for clinical trials. 

Part V. Effective and New Methodologies in Expediting New Product Approvals in the U.S. and European Union... 

Environmental considerations are just some of the many issues currently faced by pharmaceutical and agrochemical producers. These encompass the direct effect of their products on the environment, the impact of their production processes on the local environment and the most appropriate disposal route for waste products. Other considerations affecting choice of raw materials used include issues such as security of supply for processes that are not easy to alter. At a time when some regulatory authorities now have the power to delay new product approvals if the process is deemed not to be environmentally acceptable, the stakes are high. As such, efficiency considerations are no longer the only factors in determining the optimum configuration for a new process. 

The modern pharmaceutical market is under relentless pressure from slowing new product approvals, patent expiries and global competition. In addition, new opportunities... 

---