“Stated simply, we formulate the goop, we buy all the raw materials to mix the goop” ….. Fine, here’s your warning letter.

Every ‘small company’ likes to proclaim it’s uniqueness and the astute one’s do it simply – providing a direct yet compelling message on their website.  One such company in the SE USA includes an interview with their SVP, Contract Sales: Human & Animal Health: [#1] Q: What do you do? A: We manufacture over-the-counter drug products,…

AxoGen, Inc. Receives David J. Gury Company of the Year Award from BioFlorida

Award recognizes company’s contribution to Florida’s life sciences industry ALACHUA, Fla., Oct. 18, 2017 (GLOBE NEWSWIRE) — AxoGen, Inc. (NASDAQ:AXGN), a global leader in developing and marketing innovative surgical solutions for peripheral nerve injuries, has received the BioFlorida David J. Gury Company of the Year Award. The award, presented this week at the 20th anniversary…

Stimwave LLC Awarded DAPA

Fort Lauderdale, FL, February 2017.  Stimwave, LLC a manufacturer of The Freedom Stimulator is the smallest implanted stimulator system, was awarded a distribution and pricing agreement by the Defense Logistics Agency 24 February 2017.  This 5-year contract is the first global award for spinal cord stimulators. “We are extremely pleased to have Stimwave added to…

Unique Device Identifier – Post Marketing Surveillance

CDRH:  Strategic Priorities:  Establishing a National Evaluation System GOAL #1:  Increase access of real-world evidence to support regulatory decisions. Measurements for 2016-2017:  Gain access to 25 million electronic health records with device identification in 2016, and 100 million by end of 2017. GOAL #2:  Increase use of real-world evidence to support regulatory decisions. Measurements for…

Sponsored Prior Authorization Services

Several large manufacturers currently offer prior authorization services for certain product lines. Why would they do this given the cost and regulatory exposure? Obviously, they believe it increases the utilization of their products. How could a smaller manufacturer decide if this is a good investment? Here are a couple considerations: Is your product part of…