Newsletters

Newsletters

2017

September 2017
EMA Guideline Revisions, Exclusive Symposium and More!
August 2017
E14 Guidance Q&A, Invitation to our Exclusive Complimentary Symposium, and More!
July 2017
Guideline on ANDAs, cannabis studies and your last chance to view our webinar on the effects of drugs on driving.
June 2017
Guideline on Equivalence Studies, Metabolic Disorders and your chance to ask our experts questions directly about hot topics like Biotherapeutics and Therapeutic Equivalence.
April 2017
EMA Guideline on Trial Master File, Reliable Data, Rescue Studies and your chance to ask our experts your questions on Pain Models and CNS Studies.
March 2017
Multisite Studies, Driving Simulation, CRO Leadership Awards and Much More!
February 2017
Learn about our cannabis study, biosimilars, our diabetes case studies, and so much more!
January 2017
Learn about our experience with pain models, our latest FDA audit, our new vaping room and so much more!

2016

December 2016
On December 2nd, the FDA published a guidance intended to assist applicants in preparing the clinical pharmacology section of prescription drug labeling.
November 2016
On November 10th, the European Medicines Agency followed through on plans to update its guidance on first-in-human clinical trials.