Monthly Archives: October 2017

FDA Issues New Guidance Documents, Notable Changes to Pre-Submission Process

October 25, 2017 | Regulatory

The FDA has issued a number of guidance documents, primarily focused on the pre-submission process that medical device manufacturers use to improve the likelihood of success of a particular filing.  All of the guidance documents are commitments made as part of MDUFA IV.  A link to the announcement of these guidance documents is here.  iuvo […]

iuvo Co-Authors Paper on Socially Housing New Zealand White Rabbits

October 21, 2017 | Toxicology

October 21, 2017 – Members of the iuvo toxicology team co-authored a paper in the October 2017 issue of Comparative Medicine, the international journal of the American Association for Laboratory Animal Science. The article is entitled “Sequelae of Occult Aggression Disqualifying Young, Socially Housed, Female New Zealand White Rabbits (Oryctolagus cuniculus) from Participation in Dermal Toxicology […]