European Medicines Agency plans to increase drug maker fees

The European Medicines Agency (EMA) released its 2013 budget earlier this month per a recent article published in in-ParmaTechnologist.com.  The budget includes a 4% increase on its expenditures and projects other potential funding sources (e.g. EU) will increase...

FDA releases final guidance of eCopy Program

The FDA recently published a final guidance, “eCopy Program for Medical Device Submissions” to describe the new electronic (eCopy) Program for medical device submissions. The guidance, effective Jan. 1, requires eCopy submission for most types of device applications,...

FDA partners with Medical Device Innovation Consortium

The FDA joined the Medical Device Innovation Consortium (MDIC) in the first public-private partnership to promote medical device regulatory science. MDIC is an independent, non-profit corporation created by CDRH and LifeScience Alley (LSA), a Minnesota-based...

INpact Meeting January 23, 2013

Join Pearl staff at the first INpact lunch meeting of 2013 on Wednesday, January 23rd.   INpact is focused on supporting the medical device industry in Indiana. Please attend the lunch to network and learn more about the new bimonthly meeting format. Date:  January...