Current Issue : July-September Volume : 2016 Issue Number : 3 Articles : 2 Articles
It is the race to stop the ‘silent tsunami’ facing modern medicine. Antibiotic is one of the world’s most pressing public health threats and most important tool we have to combat life threatening bacterial disease, but using antibiotics can have side effects. It overuse increases the development of infectious germs which is drug resistant. Patient’s and healthcare providers, hospital administrators and policy makers must work together to use effectual strategies for improving antibiotic use, ultimately we saving life and promote health education and improving medical care. Antimicrobial resistance will be a great threat than cancer by 2050’....
Regulatory network in pharmaceutical industry indicates that communication and advice to various departments in industry is very essential. It plays an active role in defining guidelines nationally and internationally. There is a growing need to incorporate the current requirements of pharmaceutical industries in the standard curriculum of pharmacy colleges to prepare the students with the latest developments to serve the industries. Regulatory affairs (RA) professionals are employed in pharmaceutical industry, government, academic research and clinical institutions. RA takes care of life cycle of product like drug development plan, supervising-writing /drafting, reviewing, assembling and publishing/submission management through paper or electronically. In today’s competitive environment the reduction of the time taken to reach the market is critical to a product’s and hence the company’s success. So keeping update on regulations is essential in regulatory affairs. This review article attempts an insight on the recent regulatory aspects and marketing authorization procedures general concepts of regulatory affairs, necessity, goals, DMF, Types of DMF, IND, NDA, ANDA, CTD, eCTD, ICH, MedDRA, abbreviations etc....
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