by Katie Oakley | Jul 17, 2014
Alexander Gaffney of raps.org posted an interesting article regarding the use of Internet and social media platforms in FDA regulated industry. Many companies have been using such resources to promote products and answer customer questions; however, FDA has been known...
by Katie Oakley | Jul 10, 2014
We are pleased to announce the recent hiring of Zac Unger as a Regulatory Analyst. Unger brings a strong blend of Information Technology (IT), document publishing, and software systems to the Pearl Pathways team. To read the full press release, click here.
by Katie Oakley | Jul 2, 2014
The US Food and Drug Administration (FDA) has significant changes in regulation planned throughout the next year, as shared by Alexander Gaffney of RAPS.org. The article highlights six major proposals, five of which fall under the Drug Quality and Security Act (DQSA)...
by Katie Oakley | Jun 26, 2014
Alexander Gaffney of RAPS.org posted an interesting article regarding FDA’s new Patient-Focused Drug Development Initiative, created to obtain patients’ perspectives on the severity of their conditions and the treatment options currently available. The goal is to...
by Katie Oakley | Jun 25, 2014
We invite you to join us at the second session of Indiana Medical Device Manufacturers Council (IMDMC)’s annual Regulatory 101 course on August 19, 2014. Session two will cover the post-market requirements and compliments the discussion of pre-market requirements back...