by Katie Oakley | Oct 31, 2014
For the first time, FDA is allowing new fixed-dose combination (FDC) drugs to be eligible for five years of New Chemical Entity (NCE) exclusivity. FDA currently provides market-based exclusivity to pharma companies who have been approved to market new drugs, granting...
by Katie Oakley | Oct 29, 2014
By definition, all in vitro diagnostics (IVDs) for human use are medical devices. That much can be easily understood: however, classifying medical devices under the IVD umbrella can become complicated when the difference between each category is often unclear. There...
by Katie Oakley | Oct 24, 2014
Pearl Pathways is excited to be attending the Annual Clinical Affairs & Regulatory Approvals for Diagnostics Conference next week in Alexandria, VA. This conference provides a forum for discussion on the challenges regulators face and strategies used to...
by Katie Oakley | Oct 15, 2014
FDA has released a final guidance document and collaborated with the National Health Information Sharing & Analysis Center (NH-ISAC) as part of their effort to protect patient privacy and prevent cyber-security threats in medical devices. The guidance suggests...
by Katie Oakley | Sep 26, 2014
The National Institute for Health and Care Excellence (NICE) serves as the U.K.’s primary auditor for drug products, ultimately deciding whether or not the value and efficacy of each drug is worth the cost. With this information, it is evident why pharma companies...
