Prepare for the AWS Certified Solutions Architect - Associate (SAA-C03) exam. Learn about the AWS Management Console, S3 buckets, instances, database services, cloud security, costs associated with AWS, Amazon Elastic Compute Cloud (EC2), Amazon Virtual Private Cloud (VPC), Amazon Simple Storage Service (S3), and Amazon Elastic Block Store (EBS).
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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.