Sort By:
Date
Title
Category:

Europe vs USA: new drug product approvals in 2016

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.

| Community News, Library News, News, Translational Science

Considerations for Good Pharmacovigilance Outsourcing

Read about the importance for clients and service providers to understand and discuss each other’s needs to avoid unrealistic expectations often elicited prior to signing a contract.

| Community News, News, Pharmacovigilance

New FDA Guidance: Impact on Clinical Safety Data

This article written by NDA’s Brian Edwards and Olga Björklund explains the best way to stay compliant.

| Community News, News, Pharmacovigilance

Regulatory and HTA - The European dream of integrated requirements

|

A Core Dossier – Early planning for Global Success

|

Strategies for Success in Global Development

| Translational Science

Communicating for Approval and Market Access

Learn how you can avoid costly delays along the path to regulatory approval and commercialization in this article written by NDAs Lisa Peluso.

| Community News, Library News, News, Services News, White Papers

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

NDA Intelligence

Subscribe to the latest intelligence from the true thought leaders in the field and access it at any time.

Sign In

Create Account

By signing up you are agreeing to our terms of service