by Eamon Casey | May 20, 2014
Alexander Gaffney from raps.org released an interesting article on FDA’s completion of the rewrite of device pre-submission guidance. FDA issued a guidance document to outline the changes and why these meetings are so important. They believe that the meetings offer a...
by Eamon Casey | May 7, 2014
Plan on joining us at the Indiana Medical Device Manufacturers Council (IMDMC) event entitled “Regulatory 101” on May 15, 2014. Gretchen Bowker, COO of Pearl Pathways will be speaking at the event at the Montage Banquet Hall in Indianapolis, Indiana. This is a full...
by Eamon Casey | May 7, 2014
FDA released a final rule in January 2014 regarding required pediatric information that must be included in medical device PMA, HDE, and PDP submissions in order for the devices to be approved. To review the Final Rule entitled “Medical Devices; Pediatric Uses of...
by Eamon Casey | Apr 28, 2014
Alexander Gaffney from raps.org wrote an intriguing article on productivity gaps that are haunting FDA and the drugs that are in great need of approval. The Manhattan Institute for Policy Research (MIPR) created a report to objectively examine FDA’s speed on reviewing...
by Eamon Casey | Apr 28, 2014
Varun Saxena from fiercemedicaldevices.com wrote an interesting article on the proposed plan of Expedited Access PMA (EAP). The FDA talked about how EAP is not a new path to market but a collaborative approach to facilitate product development under existing FDA...
