NDA’s Dr Mira Pavlovic-Ganascia and Claes Buxfeldt provide insight on what the expected outcomes of constructively engaging with regulators and HTA bodies could be.

Business Sweden, together with SwedenBIO, have outlined the current state of Swedish orphan development in a new report. It describes a vibrant drug development landscape that is reflective of the global move towards orphan development and the strong emphasis on oncology.

An insightful interview with NDA’s Claes Buxfeldt, HTA Director, entitled “Observations of a market access expert” featured in Aprils edition of Pharmafocus.

What are the key differences in new drug product approvals across the US and EU regions? Learn about the state of drug approvals in the world's two largest markets.

NDAs Paula Salmikangas discusses how the Quality Target Product Profile (QTPP) can be put to best use when developing ATMP’s.

NDAs Neelu Agrawal describes the unique challenges, along with key factors for success when preparing for an advisory committee for a rare disease.

NDAs Paul Chamberlain provides practical advice about how to present immunogenicity-related information in regulatory dossiers in the latest publication of Bioanalysis.

In this article written by Dr Terese Johansson, Regulatory Consultant, you can read about how recent developments in tumourigenesis genomics have paved the way for a molecular marker defining a disease that spans multiple histology-based tumours in a tissue-agnostic manner.

On Thursday 4th October, at the prestigious Royal Society of Medicine in London, the Chartered Institute of Ergonomics & Human Factors (CIEHF), launched their much-awaited White Paper setting out CIEHF's vision for the integration of Human Factors in Health & Social Care.

This article, written by two of our experts, addresses recent findings from the EMA PRIME scheme and provides information about procedural updates and evolving guidance in the ATMP area.

NDAs Eva Lilienberg details the levels of support pharmaceutical companies can expect to receive from the authorities and how to best prepare for any agency interactions in the latest SwedenBio’s fact sheet.

Prepare for partnering – Optimizing value in early development.

Learn about the rationales and results of engaging early with regulators and HTA bodies in this white paper written by NDAs Dr. Mira Pavlovic-Ganascia and Claes Buxfeldt.