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Europe Vs USA: new drug product approvals in 2015

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 in this NDA article by Olga Björklund.

| Community News, News, Services News, Social News

Adapting to new clinical trial regulation in EU

NDA's Olga Björklund and Brian Edwards have written a commentary about the EU Clinical Trial Regulation coming into effect by October 2018 at the latest.

| Community News, News

Controversies in Establishing Biosimilarity: Extrapolation of Indications and Global Labeling Practices

| Community News, News

Managing uncertainties – early dialogue for early market access in Europe


Immunogenicity: anticipating and avoiding issues for biopharmaceutical development

NDA Advisory Board member, Paul Chamberlain, has just had an article titled Immunogenicity: anticipating and avoiding issues for biopharmaceutical development, published in Drug Target Review.

| Community News, News, Social News, Translational Science

Advances in analytical characterization of biosimilars

Dr. Frits Lekkerkerker, NDA Advisory Board member, has written an article titled “Advances in analytical characterization of biosimilars” that was published in GaBI, Generics and Biosimilars Initiative Volume 4 Issues 3.

| Community News, News

Industry and Academia Partnering to Advance Prevention and Treatment of Alzheimer’s Disease

| Community News, News, Social News

Risk Evaluation and Mitigation Strategies - Feedback from GPvP seminar

| Library News, News

Achieving safe and timely access to medicines

This commentary by NDA CEO Johan Strömquist is focusing on what Europe is doing – from a regulatory perspective – to promote access to new medicines and was published in the June issue of MedNous.

| Community News, News, Services News, Social News

Optimised drug-development: Integrating regulatory and HTA


Clinical Development of Gene Therapy


Pharmacovigilance for biologicals: the impact on global drug safety

NDA Group’s Dr Brian Edwards has written an article addressing the needs of a more flexible and adaptive approach for the concept of organised data collection.


Europe Vs USA: new drug product approvals in 2014

In recent weeks, we have gathered together the data made publicly available on the state of new drug product approvals in the EU and the US. This report is based on the approval status reported on the FDA and the EMA official websites on March 4th 2015.

| News, Services News

Drug Approvals Infographic EU vs USA 2014

Nearly 40% of new products approved from non top pharma in 2014. Findings of new Infographic highlights state of drug approvals in 2014: EU vs USA

| Community News, News, Social News

What are the benefits of a 'global' dossier?

Optimizing the use of the regulatory file: Is a ‘global’ dossier possible? Even though the CTD has been mandatory in the EU and Japan and has been strongly recommended in the US since the early 2000s, differences remain over content and format requirements. When compiling the first application file, many companies focus on one geographic area and re-write large parts of the documentation to encompass other country or regional requirements.


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