by Raleigh Malik | Apr 10, 2013
According to a recent article on Pharmatimes.com, the FDA plans to issue guidance describing which medical apps on mobile devices will be subjected to FDA approval. With the advent of multiple new medical apps, the FDA plans to regulate mobile devices that perform...
by Raleigh Malik | Apr 10, 2013
Health Canada issued guidance on March 4, 2013 entitled “Factors Influencing the Classification of Products at the Device-Drug Interface” which finalizes the guidelines for classification of therapeutic devices or drugs. The focuses of the guidance were to clarify...
by Raleigh Malik | Apr 3, 2013
Pearl’s Diana Caldwell and other industry professionals will discuss the impact of the service sector on life sciences in Indiana at the April IHIF Lunch Series. Topic: “Indiana’s Life Science Service Sector” When: Tuesday, April 16, 2013 Time: 11:30-1pm Location:...
by Raleigh Malik | Mar 27, 2013
In an effort to reduce the costs, Health Canada announced that it is only accepting administrative regulatory submissions in either electronic common technical document (eCTD) format or as a Portable Document Format (PDF) file beginning June 1, per a recent article on...
by Raleigh Malik | Mar 27, 2013
FDA recently issued draft guidance, entitled “Distinguishing Medical Device Recalls from Product Enhancements and Associated Reporting Requirements.” The guidance was issued to clarify when a change in a medical device product warrants a recall. Additionally, the...
