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TOPRA

EU HTA Regulation: ‘We Don’t Want An Empty Dossier,’ Warns Coordination Group

Manufacturers that do not answer all questions they are asked during joint clinical assessments under the upcoming EU HTA Regulation could have their applications deemed incomplete, says a co-chair of the JCA subgroup.

EMA To Test New Ways Of Managing Conflicts Of Interest

The European Medicines Agency is mulling how best to involve experts in its decision-making processes while avoiding potential conflicts of interest, says executive director Emer Cooke.

EMA And FDA Eliminating ‘Needless Differences’ – Particularly For Rare Diseases

US and EU regulators have invited two companies to work with them on a pilot scheme for assessing drugs for rare genetic diseases, a move that the European Medicines Agency’s Emer Cooke said would help improve “global alignment.”