The RAPS Indiana Chapter presents the expert presentation, “The New FDA Landscape in Medical Device Development.” Where: MED Institute Inc., West Lafayette, IN When: September 11, 2012 from 5:15 – 8 p.m. Cost: $40 for non-members and $25 for members Stay current on...
According to an article on Outsourcing-Pharma.com, there is a dire need for strong, clear communication between entities when transferring IRB responsibilities. The article, entitled “Sponsor – CRO communication critical to IRB transfer; FDA,” states that all...
Check out this article which discusses some strategies to better communicate with regulatory agencies in the preclinical stage of drug approval. Some of the major themes highlighted are to stay consistent and accurate when discussing your product, think twice about...
FDA recently issued a warning letter to clinical investigator Betty Tuller, PhD, after she purportedly violated several requirements under 21 CFR Part 312 while working at Florida Atlantic University’s Center for Complex Systems and Brain Sciences. According to the...
The FDA will hold a 2 day public hearing to obtain input from those interested in FDA’s scope and direction in modernizing regulations, policies, and practices that apply to clinical trials of FDA-regulated products. Anyone interested is strongly encouraged to...
