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New Drug Approval Process - Fourth Edition Accelerating Global Registrations

Offering expert guidance on the clinical, regulatory, and statistical processes involved in the development of new pharmaceutical product applications for drugs, biologicals, and medical devices, the Fourth Edition details the specific regulations, guidelines, and procedures that will advance and ensure approval of United States and global new product applications. It communicates and integrates a new approach to the world of pharmaceutical personnel on all aspects of new product development and alerts readers to clinical and regulatory tasks that require immediate attention and long-term follow-up in order to comply with the international acceptance of new product approvals.




The fourth edition carries a subtitle, "Accelerating Global Registrations", pointing to the rapid globalization of the pharmaceutical industry. Regretfully all the contributors, save one, come from the U.S., mostly from the consulting and outsourcing companies and they tend to focus mostly on interaction with the U.S. Food and Drug Administration. The climbing cost of discovery and development of new drugs, the political pressures to keep the prices low, and the challenge from generic industry make their rapid approval imperative. 

In addition, the proliferation of "me too" knock-offs forces the original inventor to rapid maneuvers such as the introduction of new formulations and indications. If the safety and effectiveness of new drugs are to remain the main aim for the regulators and the regulated, the only place where the real savings can be made is the speed of the approval process. The laboriously designed and harmonized process of drug approval might itself have deadly consequences if interfered with. The past history is the best proof of that.


The book is very well organized, and each of its five parts could be read and used as an individual guide for a given phase of drug development. Part I focuses on the regulatory practices and procedures. It begins with a succinct yet comprehensive discussion of the drug development teams: the discovery, the preclinical, and the clinical. The nonclinical development, the investi- gational new drug application (IND), the new drug application (NDA), the abbreviated and supplemental NDAs, the biological license application (BLS), and the rather involved process of medical devices investigation and approval are covered in a similar manner. 

All necessary phases of development are listed in logical andchronological order, providing a useful template for an executive in charge. The topic of Part II is clinical research development where the safety and efficacy of a new drug are confirmed and proven. The substance and format of the clinical research protocols are em- phasized as being crucial for a successful conduct of the study and the eventual approval of the NDA. Part III is the only part of particular interest to the active medicinal chemist. The presentation of the CMC (chem- istry, manufacturing, and control) subject does not reflect the state of flux in which it is at present at the FDA. 


The current PAT (process analytical technology) initiative advanced at the FDA does not seem to be mentioned in the chapter. Parts IV and V are informa- tive to the point of becoming infomercials. To what extend the SMOs (site management organizations) and CROS (contract research organizations) can speed up the approval process without jeopardizing the safety and effectiveness remains to be seen.
In conclusion, the book is an informative primer on the often complicated process of drug approval.





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