The heads of the US Senate Health, Education, Labor, and Pensions (HELP) Committee on 21 May urged their fellow lawmakers not to bog down the legislation intended to reauthorise the drug and medical device user fee programmes for the US Food and ...
Phil Greenfield reports on evidence that suggests that more and more companies regard sub-Saharan Africa as a viable and stable long-term market. At Ask the Analyst, a client research and consultation service offered exclusively to subscribers of ...
The Kenyan Pharmacy and Poisons Board has issued guidance explaining the current minimum requirements for advertising and promoting drugs and medical devices in the country 1 . The guideline stipulates, among other things, the procedures that ...
Neena Brizmohun reports on progress being made by the tripartite initiative. An initiative that involves Japan, China and South Korea co-operating on clinical trials for drugs has made three important advances relating to its aim of facilitating ...
China and India remain on the priority watch list of countries that the US says cause the "most significant" concern in terms of insufficient intellectual property rights (IPR) protection or enforcement or limited market access for those relying on ...
Pharmaceutical companies hoping for improvements in the Russian clinical trial environment will be encouraged by a provision in a recent draft law aimed at abolishing the requirement for foreign firms to carry out local trials when seeking a new ...
England's Department of Health has rejected a news report claiming that it has again marginalised the role of the National Institute for Health and Clinical Excellence ( NICE ), the health technology appraisal body for England and Wales, under the ...
The International Conference on Harmonisation has finalised a guideline explaining quality-related requirements for developing and manufacturing drug substances, both chemical and biotechnological/biological entities 1 ,2 . The guideline fills a ...
The International Conference on Harmonisation has approved plans for developing a new guideline on rodent carcinogenicity testing of human drugs 1 . The document, when finalised and adopted, could result in fewer drugs requiring two-year rodent ...
Brazil is proposing to fast-track a large proportion of applications it receives for clinical trials of medicines and devices to be conducted in the country 1 . International studies that have already been approved in the EU, the US, Japan, ...
From April 2013, the registered marketers of all medical devices in Brazil will be subject to new legal obligations affecting adverse event reporting requirements and corrective actions relating to their products 1 . The various field actions that ...
When the US Supreme Court invalidated diagnostic methods patents held by Prometheus Laboratories in a 20 March decision, John Whealan, associate dean for intellectual property law studies at George Washington Law School, said he found himself in the ...
