Sentence examples for drug authorisation from inspiring English sources

Assume that a new molecule M is being submitted for orphan drug authorisation, and that there is already an existing drug D for this indication.

The resulting relationship can be used to provide input to the assessment of new active compounds for which orphan drug authorisation is being sought.

In the current application, conversely, dissimilarity is of at least as much importance as is similarity; indeed, it is arguably of greater importance for a company applying for orphan drug authorisation.

The EU provides a range of incentives to encourage the development of orphan drugs, the most important of which is a high level of market exclusivity: once a medicine has been awarded an orphan drug authorisation by the European Commission, no similar medicinal product can be brought to the European market for a period of ten years.

In conclusion, we must emphasise that we are not suggesting that a computational procedure could be used as an alternative to, let alone a replacement for, the current processes used to evaluate applications for orphan drug authorisations.

10 11 12 13 Research on repeat prescribing has been largely quantitative, comprising retrospective surveys of conditions, drugs, authorisation dates, clinicians' views, 2 14 15 16 17 and experimental or quasi-experimental studies of interventions aimed at improving efficiency or safety.

In the USA, F-MISO has investigational new drug (IND) authorisation from the Food and Drug Administration FDAas an an investigational product for use in humans.

There is growing interest in characterising factors associated with positive regulatory outcomes for drug marketing authorisations.

For orphan drugs, market authorisation is considered proof of additional benefit by German regulations [§35a (1) German Social Code Book V], but only up to an annual revenue of 50 million Euros.

In the period in question, 48 anti-cancer drugs obtained authorisation for sale from the European Medicines Agency, with 68 specific indications.

This includes a recently lengthened period of data exclusivity the years after a patent expires during which copycats are excluded from using data from the original inventor's tests or clinical trials of a drug to get authorisation for a generic version.