France's drug regulatory agency, Afssaps , has published details of the new membership of its various bodies and committees, including those responsible for drug approvals and pharmacovigilance 1 ,2 . The move is noteworthy because the ...
Priorities for the European Medicines Agency in the drug safety area this year include a new urgent referral procedure, guidance on post-authorisation efficacy studies and more effective ways of detecting and acting on significant safety signals. ...
Moves towards implementing a Europe-wide system for verifying the authenticity of medicines are gathering pace as representatives of the pharmaceutical industry and distributors prepare to sign an agreement on what they say will be a "practical and ...
The UK Medicines and Healthcare products Agency has taken the first steps towards preparing an economic impact assessment of the anticipated costs to the pharmaceutical industry in meeting the regulatory obligations of the the EU's falsified ...
The US Food and Drug Administration has failed to take the necessary steps to ensure that the labels of marketed antibiotics are kept sufficiently up to date to help clinicians determine the best antibiotic to treat a particular bacterial infection, ...
A group of US senators has demanded to know the rationale and scientific data Health and Human Services Secretary Kathleen Sebelius used to base her 7 December decision to block the US FDA's approval to permit Teva to market its single-pill ...
The US Food and Drug Administration has released the results of a study that was conducted in support of the agency's plans to establish standards for drug sponsors with regard to communicating a medicine's side effects clearly in TV advertisements ...
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 ...
Mexico's healthcare products regulator, Cofepris , has agreed to expedite the review of certain medical devices that are registered in Japan, under an equivalency agreement 1 . The agreement, which will apply to devices registered in Japan as Class ...
The European Commission has asked Greece to amend its legislation on the parallel trade of medicines in order to comply with the EU rules on the free movement of goods 1 . The commission notes that current national measures and/or practices in ...
The European Commission is inviting comments on its plans to extend the scope of the European variations regulation (Regulation (EC) No 1234/2008) to purely national procedures 1 ,2 . Stakeholders have until 22 October to submit feedback on the ...
The European Medicines Agency has issued for consultation a draft guideline on the stability data it expects manufacturers to generate to support a variation to a marketing authorisation 1 . The document deals with stability testing for type I (A ...
