by Samme Jancin | Aug 10, 2015
Recently, the US Food and Drug Administration (FDA) has approved the first 3-D printed drug. This drug was created by a private company located in Pennsylvania and has up to 1,000mg of levetiracetam in it. The reason for this drug is to help those who have trouble...
by Samme Jancin | Aug 6, 2015
On August 5th, the US Food and Drug Administration (FDA) released a new guidance on 510(k) submissions. This guidance is called “Refuse to Accept Policy for 510(k)s” and the plan is for it to be in effect this October. The reason for this new guidance is to provide...
by Samme Jancin | Aug 6, 2015
President and CEO of Pearl Pathways, Diana Caldwell, was featured in the Health Businesswomen’s Association (HBA) “meet the membership series” in an email newsletter on July 20th, 2015. Caldwell was asked a series of questions relating to her start-up of Pearl...
by Samme Jancin | Aug 4, 2015
This week the US Food and Drug Administration (FDA) released its draft guidance on how to advance risk-based inspections and improve issues with drug shortages. Earlier this year, FDA created the Office of Pharmaceutical Quality (OPQ) to help look at drug product and...
by Samme Jancin | Jul 30, 2015
The Indiana Clinical and Translational Sciences Institute is hosting its 7th annual meeting on September 11, 2015. Young researchers will be recognized and a major highlight of the event will be the awarding of the second Watanabe Prize in Translational Research to...
