IPEC-Americas Submits Comments on FDA’s ANDA Submissions – Refuse-to-Receive Standards…
18. February 2015 IPEC-Americas Submits Comments on FDA's ANDA Submissions - Refuse-to-Receive Standards Guidance for Industry …
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List of US FDA DMF Type IV as per 4th quarter 2014
09. February 2015 List of US FDA DMF Type IV as per 4th quarter 2014 List of active DMF Type IV as per…
Spectrum Pharmaceuticals Files a New Drug Application with the FDA for Captisol-Enabled™ (Propylene…
29. December 2014 http://www.businesswire.com/news/home/20141226005014/en/Spectrum-Pharmaceuticals-Files-Drug-Application-FDA-Captisol-Enabled™#.VKGD-50HAIM…
List of US FDA DMF Type IV as per 3rd quarter 2014
18. December 2014 List of active DMF Type IV as per 3rd quarter 2014 The list is…
FDA Outlines Upcoming Regulatory Changes And Urges Industry To Be Proactive And Transparent
22. November 2014 http://www.pharmaceuticalonline.com/doc/fda-outlines-upcoming-regulatory-changes-and-urges-industry-to-be-proactive-and-transparent-0001…
FDASIA- One Year Later: The Current Status and Impact on Excipients
10. September 2014
by Bretta Lichtenhan (EMD Millipore) - IPEC Americas at ExcipientFest Europe in Amsterdam, June 2014
https://newsismybusiness.com/excipientfest-americas-slated/
China’s FDA Voices Interest in Developing an Excipient DMF System at Meeting with IPEC China; India…
01. June 2014 May 30th, 2014 China is among countries giving consideration to Establishing a drug master file (DMF) system for excipients, as regulators…
US FDA issues new bioavailability guidelines
25. March 2014 By Dan Stanton+, 25-Mar-2014 The US FDA has published guidance of how sponsors should best document the bioavailability of products for investigational new…
Gastrointestinal Permeation Enhancers Beyond Sodium Caprate and SNAC – What is Coming Next?
Abstract
Oral peptide delivery is trending again. Among the possible reasons are the recent approvals of two oral peptide formulations, which represent a huge stride in the field. For the first time, gastrointestinal (GI) permeation…
A review of hot melt extrusion technology: Advantages, applications, key factors and future…
Abstract
After decades of development, hot melt extrusion (HME) technology has matured as a well-established pharmaceutical methodology. Through the process of extruding both drug and carrier materials in a molten state under specific…