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 what constitutes a drug or device and support a more standardized regulatory process. To read the final guidance, click here. Contact us at 317-899-9341, if you need assistance with your medical device submission.
Obstacles Facing Biosimilars
Still in its infancy in the U.S., the industry faces some growing pains.
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