by Michele Taylor | Aug 11, 2016
We are proud to announce that Gretchen Parker PhD, RAC, CIP contributed a chapter to a recent publication entitled “Global Medical Device Regulatory Strategy” published by the Regulatory Affairs Professionals Society (RAPS, purchase required). This book provides a...
by Michele Taylor | Aug 4, 2016
Hosted by IMDMC and Stericycle on September 27th, the Mock Recall Demonstration is an excellent opportunity to learn and strategize to increase efficiency in a recall situation. Attendees will team up to analyze and develop a recall strategy and more. Follow this...
by Michele Taylor | Aug 4, 2016
Join in a complimentary webinar, China Update – what’s new with CFDA hosted by our partner, Brandwood Biomedical. For the latest updates, including recent release of ruling on China RoHS coming from the CFDA, learn from Brandwood Biomedical Director of China...
by Michele Taylor | Jul 29, 2016
FDA released its “goals letter” on performance goals and procedures for the Prescription Drug User Fee Act (PDUFA) for 2018 – 2022. This is important news about the human drug review program — both for industry and patients. FDA is holding a public meeting on...
by Michele Taylor | Jul 22, 2016
Orphan Drug products give patients with rare diseases hope. The Orphan Drug Act, originated in 1983, features incentives for companies to develop drugs to treat a rare disease or condition by giving tax credits on clinical trials, eligibility for seven years of market...
