Drug approvals in the

Walsh, G. 2006. Drug approval in the European Union and United States. In An Introduction to Molecular Biotechnology, Wink, M. (ed.). Wiley-VCH pp. 651-662. 

Evers, P.T. (1985). New Drug Approval in the European Union. Parexel, Waltham, MA. 

While faster approval times benefit the industry financially, a comparison of new drug approvals In the U.S. and the UK between 1971 and 1992 has shown that they are also associated with a greater number of withdrawals due to safety problems that are missed in the pre-marketing review (Abraham and Davis 2002). Supporting that position, a 2001 survey of FDA reviewers by the OIG found that 40 per cent who had been at the agency at least five years indicated that the review process had worsened during their tenure in terms of allowing for in-depth, science-based reviews (OIG 2003). 

Mathieu, M. New Drug Approval in the United States. Worldwide Pharmaceutical Regulation Series. Waltham, MA PAREXEL International, 1998. Mathieu, M. New Drug Development A Regulatory Overview, rev. 3rd ed. 

Many of the medical products reviewed here find multiple applications. Thus procaine compounded with benzylpenicillin, penicillin G is an antimicrobial veterinary drug, approved in the US as a postexposure prophylaxis following inhalation of anthrax, providing that the strains do not have penicillin resistance. 

Natio C, Yasuhova H. 1993. Retrospective survey of pharmacokinetics dosage of 80 drugs approved in the EC, Japan, and US . E5 Workshop Reports, ICH-2, Orlando. 

Application of a worldwide sales ratio beginning with FDA approval ignores the revenues that accrue when products are launched in other countries before the FDA approves them.19Fig-ure 4-6 charts the frequency of early approval in other countries for the NCEs approved by FDA in 1981-83. Over 25 percent of drugs approved in the United States in this period were first approved at least 5 years earlier in another country. The revenues realized in the years before FDA approval are potentially very significant in terms of the present value of revenues, but without access to foreign sales data it is impossible to estimate their size. To be conservative, OTA excluded early foreign sales from the analysis. 

In addition to other data collection and analysis tasks, OTA conducted a survey of clinical trial sizes for drugs approved in the late 1970s versus the mid-1980s. 

Burlington, D. B., remarks at Drug Approvals in the United States and Abroad, seminar sponsored by the Institute for Alternative Futures Foresight, Washington, DC, October 7, 1991. 

Drug Approval in the European Union and the United States... 

Kaitin, K.I. DiMasi, J.A., 2011. Pharmaceutical innovation in the 21st century new drug approvals in the first decade, 2000-2009. Clinical Pharmacology and Therapeutics, 89(2), pp. 183-188. 

Safety-related attrition continues to be a major concern in the pharmaceutical industry (Kramer et al., 2007). Of a total of 548 drugs approved in the period... 

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