India consults on data requirements for drug trials, BA/BE studies
This article was originally published in SRA
India's Central Drugs Standard Control Organization has issued a draft guideline explaining proposed requirements for submission of chemical and pharmaceutical information, including stability study data, for the approval of clinical trial and bio-availability/bio-equivalence studies1.
You may also be interested in...
While the Dutch government negotiates an acceptable price for Leadiant Biosciences’ orphan drug CDCA, a university hospital has resumed supplying pharmacy compounded versions of the drug after addressing initial problems with the sourcing of raw materials.
The European Court of Justice has confirmed the European Medicines Agency’s approach to disclosure of data submitted as part of a marketing authorization application. It is a big disappointment for industry, which nonetheless says it supports responsible data sharing and will support efforts to develop a balanced approach.
An EU pilot project will assess whether there is sufficient demand from companies to obtain simultaneous scientific advice from EU national competent authorities.