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NDA Medical Device Division launched

We are proud to announce the creation of a new division within NDA, focusing on advice and support to companies facing increasing regulatory challenges in the device space.

| Homepage News, News, Services News

Hopes and challenges in the future of the immuno-oncology field

There is no doubt that the area of oncology development has exploded in the last few years.

| Homepage News, Oncology

The future of NDA in the Nordics

What makes NDAs new General Manager for the Nordics, Robert Kronqvist, tick?

| Community News, Homepage News, News, Services News, Social News

What do we need to know before the next influenza pandemic?

Earlier this year the 2nd International Alliance of Biological Science meeting was held to review the status of the current knowledge regarding the relationship between narcolepsy and the administration of the adjuvanted pandemic influenza vaccines.

| Community News, Homepage News, News, Services News, Vaccines

Global capabilities for local growth

In this commentary, NDA's Johan Strömquist and Thomas Lönngren provide their reflections on the unique opportunities the Nordics present for the Life Science sector.

| Events & Presentations, Homepage News, Leadership Team, Library News, News, Social News

Prime - The European approach to expedited pathways

In this white paper, Steffen and Eva discuss the different tools available to European regulators and the experiences so far with the PRIME pathway.

| Homepage News, Library News, News, Pre-submission, Regulatory Advisory Board, White Papers

European Regulatory Meetings - how best to prepare and perform

In this article, NDA's Steffen Thirstrup discusses three important factors to help you prepare for high stakes meetings with EU Regulators.

| High-stakes Meeting Preparation, Homepage News, Library News, News, Regulatory Advisory Board

Importance of Excellence in Scientific and regulatory Communication

In this white paper, PharmApprove's Lisa Peluso discusses how  excellent communications are  the backbone of streamlined, efficient programs achieving approval and market access.

| High-stakes Meeting Preparation, Homepage News, Library News, News, Pharmapprove, White Papers

Why should you engage early with regulators and HTA bodies?

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.

| Health Technology Assessment, Homepage News, Library News, News, White Papers

The state of the Swedish orphan pipeline

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.

| Homepage News, News, se

4 ways that HTA will change under the new European regulation

In this white paper NDA's CEO, Johan Strömquist, discusses four ways that Health Technology Assessments will change under the new proposed European regulation.

| Health Technology Assessment, Homepage News, Library News, News, White Papers

Observations of a market access expert

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

| Health Technology Assessment, Homepage News, News

Europe vs USA: new drug product approvals in 2018

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.

| Homepage News, News, Presentations and Infographics

Design and optimisation of a quality target product profile for ATMPs

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

| Homepage News, Translational Science

Rare Diseases and FDA Advisory Committees: Be the Experts in the Room

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

| High-stakes Meeting Preparation, Homepage News

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