by Michele Taylor | Sep 13, 2016
Unique Device Identifier (UDI) provision implementation is proving to be a large undertaking — a project involving many dependent tasks with multiple stakeholders including supply chain, pharmacies and payers. “The UDI Rule, established in the Food and Drug...
by Michele Taylor | Sep 8, 2016
The 8th annual meeting of the Indiana Clinical and Translational Sciences Institute (CTSI) is being held on September 23rd. At the event, Indiana CTSI is presenting the Watanabe Prize in Translational Research to Dr. Robert Lefkowitz, a Nobel Laureate in chemistry....
by Michele Taylor | Aug 31, 2016
FDANews reported in a recent article that 15 new warning letters were issued to device manufacturers for GMP violations. One letter was issued to a U.S. company with the remaining 14 issued for foreign manufacturers. The warning letters were issued after FDA...
by Michele Taylor | Aug 29, 2016
Striving for greater alignment in regulatory approaches, both FDA and Health Canada are continuing work to put in place the Common Electronic Submissions Gateway (CEGS) to allow industry to submit simultaneously to both regulators. Full functionality is expected to...
by Michele Taylor | Aug 22, 2016
Join us at the annual RAPS Regulatory Convergence in San Jose, CA from September 17-20. Learn more about how to drive regulatory excellence and visit us at booth #111. Some of the biggest challenges in the regulatory industry will be addressed in this year’s...
