Combination Product Industry News & Guidance Sharing device-related information and wisdom that will help you succeed Seven Common Misconceptions About Implementing A Combination Product Quality Management System While a Combination Product is made up of a drug...
Combination Product Industry News & Guidance Sharing device-related information and wisdom that will help you succeed INDUSTRY NEWS BRIEF: E-Labeling…Too Soon? You may be seeing evolving regulatory requirements about e-labeling, and beginning to weigh the...
Combination Product Industry News & Guidance Sharing device-related information and wisdom that will help you succeed INDUSTRY NEWS BRIEF: Don’t Misinterpret the New MDR Extension It is official. The European Parliament has passed the proposal originally...
Combination Product Industry News & Guidance Sharing device-related information and wisdom that will help you succeed INDUSTRY NEWS BRIEF: When patient access to important therapy is delayed… If you’ve got a new combination product drug/device that will likely...
Combination Product Industry News & Guidance Sharing device-related information and wisdom that will help you succeed INDUSTRY NEWS BRIEF: New Draft Guidance on Content of Human Factors in Medical Device Marketing Submissions The FDA recently published new...