This module outlines the legislative and regulatory context for the development of generic drugs and describes the essential role of the Abbreviated New Drug Application (ANDA) in gaining marketing approval. The use of information in the ‘Orange Book’ is explained, as is the role of patent certification in the application. The importance of establishing bioequivalence between a generic and its reference product is emphasised. The module specifies the content and format requirements for an ANDA submission and describes the FDA’s review and approval process. An outline is given of the Generic Drug User Fee Amendments (GDUFA) and the law’s effects on industry players.
Build 9 projects to master 2 essential and modern technologies: Python and PostgreSQL
Scrum Developer Certified (SDC®) is an entry level certification for Scrum Team members (developers) and those who interact with any Scrum Team. The objective of this certification is to ensure that Scrum Team members know enough about Scrum to effectively contribute to a Scrum project. The courseware and preparation tools required for the certification exam will be available online on SCRUMstudy.com. An online proctored exam will be conducted at the end of the course.
Explore the rich tapestry of political ideologies in the course 'Political Ideas: Different Forms of Politics.' From liberalism to ecologism, delve into the core principles, historical contexts, and contemporary relevance of various political ideologies, fostering critical analysis and interdisciplinary perspectives.