The drug regulatory authority

FDA's new authority on drug shortages.

Drug companies may be required to report shortages sooner, but the FDA legislation still lacks power.

Who's Responsible? How the Assignment of Regulatory Authority Influences Regulatory Effort

This paper analyzes how choices involving the assignment of authority for public goods provision to alternative sets of jurisdictions within a multi-tiered government affect both the average quantity of the public good provided as well as the variation of that quantity across jurisdictions. An empirical illustration considers the example of the California hazardous waste program. This situation...

Competency assurance of general practitioners--role of regulatory authority.

Canadian drug regulatory framework.

The role of regulatory drug submission evaluators in Canada is to critically assess both the data submitted and the sponsor's interpretation of the data in order to reach an evidence-, and context-based recommendation as to the potential benefits and potential harms (i.e., risks) associated with taking the drug under the proposed conditions of use. The purpose of this document is to outline the...

Controlling medicine prices in Sudan: the challenge of the recently established medicines regulatory authority.

This study evaluated the capacity of the medicine pricing mechanism of the National Medicines and Poisons Board (NMPB), the medicine regulatory agency of Sudan, in controlling prices of imported medicines. The study was conducted between July and September 2008 and data on the 50 most sold medicines in 2007 were obtained from the records of the regulatory authority and pharmacies in Khartoum; 1...