Regulatory Affairs Consultant Tag

In the past, FDA’s guidance on post approval changes made to New Drug Applications (NDAs), Abbreviated New Drug Applications (ANDAs), and Chemistry Manufacturing and Controls (CMC) has been ambiguous and hindered continuous improvement of pharmaceutical manufacturing processes. NDA and ANDA holders are expected to perform...

Since its creation in 2002, the Office of Combination Products (OCP) has been tasked with developing regulations and guidance documents for combination products [1]. A combination product is a product composed of any combination of drug/device, drug/biologic, biologic/device, or device/drug/biologic [2]. The three types of...