Chapter

Delegated and implementing acts in the regulation of pharmaceuticals – an analysis through the lens of subsidiarity

November 2018

DOI:10.4337/9781788115230.00011

In book: The Legislative Choice Between Delegated and Implementing Acts in EU Law (pp.117-144)

Authors:

Sabrina Röttger-Wirtz

Maastricht University

ResearchGate has not been able to resolve any citations for this publication.

ResearchGate has not been able to resolve any references for this publication.

Article

Antibiotic development

September 2008

D. Griffin

Over the last 25 years, the development of new antibiotics has decreased alarmingly (1). The cost of developing any new drug is generally in excess of US$500 million, and it usually takes eight to 10 years from identifying a potential drug candidate to the time it is launched into the market (2). In addition to this, many countries have implemented increased regulation of antibiotic usage, and ... [Show full abstract] there has been a tightening of requirements to obtain regulatory approval of drugs (1). It is not surprising, therefore, that many pharmaceutical companies consider antibiotic research to be of lower financial attractiveness compared with that for other chronic indications (such as depression or heart disease, for example).