Drugs regulatory process

Crooke, S. (1995). Comprehensive reform of the new drug regulatory process. Bio j Technology 13, 25-29. 

The CDER Forum for International Regulatory Authorities provides information about the U.S. drug regulatory processes in an organized and integrated manner. It will explain the role of CDER as well as the science, technology, regulations, and processes used to do our work. 

Immunology Drug regulatory process pharmacotherapy of pharmacotherapy... 

Saknonson, T. and Rane, A., Clinical pharmacokinetics in the drug regulatory process, Clin. Pharmacokinet., 18 177-183, 1990. 

The Federal Drug Administration (FDA) describes the biopharmaceutical industries as self-regulated, retaining for itself the responsibility of assuring and checking on that self-regulatory process. Not surprisingly, then. 

Besides stiuctural constraints, e.g. human and financial resources, the way in which DRA employees perceive their jobs and how they perform are key factors in drug regulation performance. A clear sense of mission on the part of employees is important if regulatory processes are to be pursued consistently. 

The task of the DRA is to serve the public. Its operations must therefore be transparent to both clients (e.g. drug manufacturers) and consumers. Communication with clients should be a routine activity throughout the regulatory process. Information regarding its functions and the results of decisions should also be communicated regularly to the public. 

New Drug Approval Process Clinical and Regulatory Management,... 

This chapter will review some of the important methods for carrying out in vivo absorption and bioavailability studies, as well as attempt to provide an overview of how the information may be used in the drug discovery process. The chapter is aimed at medicinal chemists and thus will focus on the use of animals in discovery phase absorption, distribution, metabolism, and excretion/pharmacokinetic (ADME/PK) studies, rather than the design of studies that are for regulatory submission, or part of a development safety package. 

The emphasis at this stage of the drug development process is upon assessing safety. Satisfactory pharmacological, and particularly toxicological, results must be obtained before any regulatory authority will permit commencement of human trials... 

Lever (1987) presents an excellent overview of the regulatory process involved in FDA oversight of drug development, and gives the historical perspective for the evolution of the conservative process that is designed to ensure that any new pharmaceutical is both safe and efficacious. 

---