By Roz Sweeney, Ph.D., Nerac Analyst,
Originally Published: June 15, 2015
Social media is becoming increasingly important for promoting the messages of medical technology companies. Sites like Twitter, LinkedIn, Facebook, and Google Plus are important sources of product information and updates for patients, doctors, payers, and investors. The FDA is also using these social media sites to communicate with the public about product recalls, approvals and regulatory changes.
- 39By Roz Sweeney, Ph.D., Nerac Analyst Originally Published: November 17th, 2014 Introduction The FDA recently issued updated draft guidance for proposed regulatory changes affecting laboratory developed tests (LDTs). Laboratory developed tests (or LDTs) are traditionally IVDs developed and used by CLIA labs for treating or testing patients within that lab’s associated healthcare facility. They have…
- 36New analyst brings experience in medical devices, neuroscience and biology. Read the full release here.
- Commercialization Strategy for Innovative Products: The Importance of Considering Regulatory Implications32By Donna Mitchell-Magaldi, M.S., Nerac Analyst, Originally Published: March 8, 2016 You have a great idea for an innovative product, a granted patent, and you are ready to assess market and commercialization feasibility. Do you know the important questions you will need to answer? Possibly the most important questions are: What are the regulatory pathways…