Pearls of Wisdom
Pearl Pathways – We’re hiring: Sales and Marketing Associate
Pearl Pathways is a small entrepreneurial minded life sciences services company poised for success, and positioned for growth. This is a great opportunity to join our company as a Sales and Marketing Associate and help us grow our business to the next level. Click...
Reminder of eCTD Deadlines Approaching
A reminder that Electronic Common Technical Document (eCTD) deadlines are approaching. All submissions to the FDA including NDA, ANDA, BLA and DMFs are required to be submitted in eCTD format beginning on May 5, 2017. IND submissions are required to be submitted in...
Let Pearl Pathways help with your biocompatibility concerns
Pearl Pathways invites you to look over a final guidance just released by the FDA Use of International Standard ISO 10993-1, “Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process." This encourages medical device...
News on Compassionate Use
The FDA has been working to improve the process used by physicians to request Expanded Access -- Compassionate Use to investigational drugs and biologics for their patients who need these therapies to stay alive. In a statement released in early June from FDA...
Update on OTC Drug User Fee program activity
FDA’s recent public meeting on June 10th discussing a user fee program for over-the-counter (OTC) drugs indicates new activity in this program. Expert opinion was heard at the meeting with the acknowledgement that this is a very enormous undertaking with a small staff...