by Raleigh Malik | May 6, 2013
On April 23, 2013, the FDA launched a new website, FDA’s Patient Network. According to Margaret Hamburg, FDA Commissioner, the website is anticipated to “increase patient’s interest and participation in the agency’s work and in the policies and decisions that affect...
by Raleigh Malik | May 5, 2013
The FDA released final guidance entitled “Medical Device Classification Product Codes” which helps guide the medical device industry on how to use the Classification Product Codes (CPC). The FDA uses the CPC system to keep track of devices and maintain “quality and...
by Raleigh Malik | May 1, 2013
A recent study published in the May issue of Medical Care found that medical device startup companies founded by physicians developed roughly the same number of patents as non-physician founded startups. The study, conducted by Drs. Sheryl Winston Smith, PhD and...
by Raleigh Malik | May 1, 2013
Pearl Pathways has partnered with the Hoosiers Work for Health coalition. Hoosiers Work for Health is the Indiana chapter of a national initiative that unites health consumers, biopharmaceutical company employees, vendors, suppliers and other business and community...
by Raleigh Malik | Apr 26, 2013
Companies that produce generic drugs and APIs are required to self-identify to the FDA for FY2014 under the Generic Drug User Fee Amendments of 2012. The period extends from May 1 to June 1, 2013 and FDA uses the information to determine the cost for application...