235 ABB courses

This course leads to the Mediterm Advanced Certificate in Medical Terminology (Level 3), the highest qualification in Medical Terminology, and can be studied flexibly over 20 weeks

This course leads to the Mediterm Intermediate Award in Medical Terminology (Level 2), studied over approximately 12 weeks (taking more or less time dependent on learner requirements). This course is suitable for those already working in healthcare or those who wish to start a new career in healthcare.

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.

Enhance your healthcare communication skills with our Medical Terminology and Abbreviation Course. Covering essential vocabulary, acronyms, and body systems, this course is perfect for aspiring professionals and current workers seeking to improve their understanding and application of medical language. Complete the course at your own pace and receive a certificate of achievement.

Level 3, 4 & 7 QLS Endorsed Diploma | QLS Hard Copy Certificate Included | Plus 10 CPD Courses | Lifetime Access

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The course will allow the student to learn the basic skills to carve letters in wood.

A 505(b)(2) New Drug Application (NDA) is a submission to the Food and Drug Administration (FDA) for approval to market a drug in the USA. It differs from a ‘stand-alone’ NDA in that some of the data on which the applicant relies to demonstrate safety and efficacy have been obtained from publicly available sources rather than from the applicant’s own studies. The applicant typically proposes to market a drug that is based on an approved reference product but modified in its formulation or uses. A 505(b)(2) NDA also differs from an Abbreviated New Drug Application (ANDA) for approval of a generic drug in that the applicant’s product need not be a duplicate of the reference listed drug. The 505(b)(2) pathway may be said to lie part-way between the ‘stand-alone’ NDA and generics pathways, offering a unique combination of advantages to developers. It facilitates the modification of drugs to address unmet medical needs. The 505(b)(2) application pathway accounts for about half of all new drug approvals in the USA.

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Level 3 & 4 Endorsed Diploma | QLS Hard Copy Certificate Included | Plus 5 CPD Courses | Lifetime Access