by Eamon Casey | Apr 25, 2014
The Indiana Health Industry Forum (IHIF) will hold their annual meeting May 5-6, 2014. Diana Caldwell, President and CEO of Pearl Pathways will be moderating two breakout sessions. Navigating the regulatory hurdles in medical device product development, May 6th,...
by Eamon Casey | Apr 14, 2014
Raqiyyah Pippins and Katie Riley from fooddruglaw.com wrote an informative article on FDA’s hearing on Over-The-Counter (OTC) drugs. The hearing comes at a period where there is a lot of frustration with the monograph process and FDA’s position on novel modes of...
by Eamon Casey | Apr 14, 2014
Check out Louise Zornoza’s recent coverage of a new guidance for Health Canada on raps.org . The new guidance released on April 4, 2014 covers new design and format requirements on monographs. The changes are intended to emphasize clinical relevance and make...
by Eamon Casey | Apr 9, 2014
We are very excited to announce that Gretchen Bowker will be presenting at St. Vincent Research Brown Bag Lunch Series. The series is a bi-monthly event to provide education and networking opportunities to our research professionals. Gretchen Bowker will be speaking...
by Eamon Casey | Apr 9, 2014
On January 4th, 1983 President Ronald Reagan signed into effect the Orphan Drug Act. For over 30 years, orphan drug development has grown in volume, and has had a major impact on the biopharma and diagnostics industries. With advancement in technology including...
