Pearls of Wisdom
Register now for September 21st webinar on Product Labeling by Brandwood Biomedical
Our partner, Brandwood Biomedical, is hosting a complimentary webinar Tearing down the Tower of Babel -- Asia Pacific Product Labeling. Join in the discussion on how regulatory affairs professionals deal with the many challenges of labeling requirements across the...
UDI deadline extended for products with NHRIC and NDC codes
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...
Save the date 9/23/16 – Indiana CTSI Annual Meeting
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....
FDA is sending a message to 15 device manufacturers
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...
Common Electronic Submissions Gateway (CEGS) targeted by years’ end
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...