Pearls of Wisdom
FDA asking for comments to Pre-Sub Draft Guidance
FDA plans to implement a new program, known as “Pre-Sub”, in which they will provide feedback on studies to medical device companies before they apply for marketing approval. The program is similar to an already existing process for drug companies, called a Special...
September 11, 2012–Save the date for RAPS Indiana Chapter presentation
The RAPS Indiana Chapter presents the expert presentation, “The New FDA Landscape in Medical Device Development.” When: September 11, 2012 from 5:15 – 8 p.m. Where: MED Institute Inc., West Lafayette, IN Cost: $40 for non-members and $25 for members Stay current on...
Register today for the IWL Conference—October 2, 2012
Come join us at the IWL’s Annual Women’s Leadership Conference! Pearl’s President, CEO and Co-Founder, Diana Caldwell, will be speaking about her journey of becoming a business owner, and the lessons she’s learned from running her own business. When: October 2, 2012...
Biotech companies increased R&D spending even more in 2011
According to a recent article featured in Bloomberg, although there was a cut in research costs in 2009, a report finds that investment has seen a gradual increase in the last two years, going up by 9% in 2011. With the financial slowdown, companies were in deep...
FDA to approve fewer drugs in 2012 than in previous years
Many industry analysts and journalists are speculating that FDA could approve a fewer number of drugs this year than in years previous. Citing from a recent report from Fitch Ratings, one article entitled “Sharp dip in US drug approvals forecast,” remarks that “the...