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CDRH is looking to enroll a total of nine participants in its new pilot program aimed at identifying best practices for quality product manufacturing. Read More
Heath Canada intends to begin piloting the use of its Regulatory Enrollment Process through the Common Electronic Submission Gateway for medical device applications by this summer. Read More
New draft regulation spells out qualification requirements for medical reps, including a two-year junior college degree or higher with a major in life sciences. Read More
A revision was made with the goal of striking a balance between transparent interactions and the need for healthcare professionals to “make independent decisions regarding patient care and treatment.” Read More