by Don McLean | Jun 27, 2019 | Blog
Pharmaceutical Industry News Roundup: June 2019 by Staff writer Each month, MMS shares key stories on the evolution of the pharmaceutical industry. Here is a selection of top stories to keep an eye on: FDA ‘open for business’ in considering real-world evidence,...
by Don McLean | Jun 13, 2019 | Blog
Developing Treatments for Rare Diseases – Reviewing Draft Guidance from the FDA by Amanda Beaster, PhD, Andrew Chervenak, PhD, Halina Chkourko Gusky, PhD, and Ingrid Hansen, MS New and updated regulatory guidances from the US Food and Drug Administration (FDA),...
by Don McLean | May 30, 2019 | Blog
Pharmaceutical Industry News Roundup: May 2019 by Staff writer Each month, MMS shares key stories on recent developments and news in the pharmaceutical industry. Here is a selection of top stories to keep an eye on: Submitting documents utilizing real-world data and...
by Don McLean | May 23, 2019 | Blog
Part 2: 505(b)(2) NDA – The Importance Early-Stage Planning by Ben Kaspar The unique aspects of the 505(b)(2) submission structure and label claims are perhaps best illustrated at the pre-IND planning stage. Whereas for a new chemical entity, pre-IND discussion is...
by Don McLean | May 16, 2019 | Blog
Part 1: 505(b)(2) NDA – Navigating the Regulatory Pathway by Ben Kaspar The 505(b)(2) is a New Drug Application (NDA) containing full reports of safety and effectiveness, where at least some of the information required for approval comes from studies not conducted by...
