News
Prescribing of generic PPIs and statins in Scotland
2012-02-24 In Scotland, a series of measures have been introduced since 2000 in order to encourage use of generic rather than brand-name proton pump inhibitors (PPIs)… Read More »
Commission urges Greece to make parallel trade fair
2012-02-24 The European Commission announced on 26 January 2012 that it wanted Greece ‘to establish fair play on parallel importation of medicinal products’. The Commission is… Read More »
FDA finally issues draft biosimilar guidance
2012-02-17 The long-awaited guidance for biosimilars in the US has finally arrived. FDA announced on 10 February 2012 that it had issued three draft guidance documents… Read More »
EMA risk management plans may increase prescriber confidence in biosimilars
2012-02-10 In the absence of observational (phase IV) data, EMA’s stipulation that all marketing applications for new generation biosimilars contain individual risk management plans may help… Read More »
EMA a step closer to implementing new pharmacovigilance rules
2012-02-10 In an attempt to enable better protection of public health, new pharmacovigilance legislation was adopted by the European Parliament and European Council in December 2010.… Read More »
Volume and sales of drugs on the shortages list in the US
2012-02-10 Despite record numbers of drug shortages being reported in the US, on the whole, over the past five years the supply of these drugs to… Read More »
Registration of biosimilars in Europe and the US
2012-02-10 Europe is way ahead of the US in terms of biosimilars regulation. A legal framework for approving biosimilars in the EU was established in 2003… Read More »
