In early April the EU Parliament voted to enact the Medical Device Regulations (MDR) and the In Vitro Diagnostic Regulations (IVDR). The regulations are due to be published in the Official Journal of the European Union in May 2017. Following publication, there will be a three year transition period for the MDR and a five […]
On April 13, 2017, as part of the US FDA’s continued efforts to comply with the 21st Century Cures Act of 2016, the Agency published a list of 71 low-risk Class I medical device product codes that are exempt from all premarket notification requirements (i.e. 510(k) clearance). While the list includes product codes for ophthalmic and […]
iuvo’s Director of Analytical Chemistry, Dr. Chris Houston, recently co-authored an article in the PDA Journal of Pharmaceutical Science and Technology entitled “Simulated Leaching (Migration) Study of a Model Container-Closure System Applicable to Parenteral and Ophthalmic Drug Products.” The article is available at http://journal.pda.org/content/71/2/68.full.pdf+html Dr. Houston has been with iuvo BioScience for almost two years. […]
EDITOR’S NOTE: The author, Dr. Chris Houston, serves on the PQRI-PODP working group as well as a sub-group for Ophthalmics, which is led by iuvo Chief Scientific Officer Dr. Mary Richardson. I recently attended the 3rd FDA/PQRI Conference on Advancing Product Quality held March 22-24, 2017 in Rockville, MD. I was invited to speak about […]
Last week, iuvo BioScience celebrated our second anniversary. At times, the two years seem to have flown by in an instant – memories of closing the deal, the Day One presentations in Erie, PA, and Rush, NY, the countless client calls and visits are all as fresh in my mind as if they happened yesterday. […]
