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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

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Clinical Development of Gene Therapy

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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.

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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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Making Progress with Biosimilars

NDA Group’s Dr Gopalan Narayanan has written an article addressing the market for biosimilars as a lower-cost alternative.

| Community News, News

Safety at the highest level

NDA's Dr. Edwards has written the article "Safety at the highest level" that was published in UMCs news bulletin Uppsala Reports vol 67 Oct 2014

| Community News, News

State of US and Europe new drug product approvals in 2013

Over the past couple of months we’ve researched data on the state of new drug product approvals in the EU and the US. Our findings were recently published in an Infographic.

| Library News, News

Drug Approvals Infographic

| Library News, Marketing Collaterals, News

Interchangeability. An insurmountable fifth hurdle?

| Biologics, Community News, News

Making Progress with Biosimilars

| Biologics, Community News, News

Multidisciplinary approach to evaluating immunogenicity of biosimilars: lessons learnt and open questions based on 10 years’ experience of the European Union regulatory pathway

| Biologics, Community News, Immunology, News

Adaptive licensing - How are regulators supporting innovation?

Commentary by NDA CEO Johan Strömquist on the development of expedited pathways and implications for the pharma industry.

| Community News, Library News, News

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