The European pharmaceutical industry federation, EFPIA, says its member companies are not looking for shortcuts to develop and validate digital biomarkers, but want help from regulators to create the right evidence.
Drug companies in the EU are keen to devise and validate digital endpoints, but they want regulators to simplify the current complex environment around the process, find pragmatic solutions and issue guidance that can help move the field forward and offer more clarity.
The present landscape for developing and validating digital endpoints represents a complicated mix of different regulatory and evidence generation requirements, which can vary depending on the type of tool being...
In this first in a series of articles looking at the potential impact of the MFN drug pricing policy on European pharmaceutical markets, EUCOPE’s Alexander Natz tells the Pink Sheet why the US policy underscores the importance of confidential net pricing.
ISRCTN’s systems are being redesigned to facilitate compliance with upcoming requirements in the UK’s clinical trials legislation.
Spanish authorities say that that timelines for drug reimbursement decisions can be improved further with the right submissions from companies.
Spanish authorities have published more pricing and reimbursement reports as part of a new drive to increase transparency.
The budget authority total, which is significantly higher than the amount floated in an April OMB draft document, suggests there may have been successful lobbying to increase FDA funding.
In this first in a series of articles looking at the potential impact of the MFN drug pricing policy on European pharmaceutical markets, EUCOPE’s Alexander Natz tells the Pink Sheet why the US policy underscores the importance of confidential net pricing.
The International Council for Harmonisation has identified four new topics that can benefit from global regulatory alignment, with timelines for initiating work to be determined later.
