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This book has 12 chapters covering nearly all the areas of Drug Regulatory Affairs. Various aspects of Drug Regulatory Affairs such as new drug approval procedure, pharmacovigilance, product recall, evolution of drug regulations in the United States of America (USA) and process of drug approval in the USA and European Union, bioequivalence regulations, electronic Common Technical Documents (eCTD), environmental regulations, orphan drugs pharmaceutical pricing and control policy, Pharmacovigilance system in India and the USA, Product Recall, regulations of pharmaceutical drug promotion and Pharmacy Practice regulations are covered in this book. As a whole, the book is a comprehensive reference book on regulatory affairs and will be very useful for the practicing professionals and students alike.

Interested readers may write to us at mup@manipal.edu about purchasing the book.

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Authors: Venkataraja Aithal U, Rekha Patil and B Rajashekhar

Manipal Manual of Ear Mould Making is a comprehensive workbook of value to students of Audiology & hearing professionals who wish to understand the nuances of this skill that is paramount for optimization of hearing aid fitting. This is a compilation of the authors? years of experience in the deft skills of ear mould making and patient care in Manipal Ear Mould lab. Considerable efforts have gone in to bringing out this manual by incorporating appropriate pictures, stepwise procedures and simple instructions. This manual, besides appraising the readers of the procedure would also assist them in learning the dos and donts picked up out of the authors? clinical experience. This will be a reflection of our ongoing efforts to derive the best out of the rapidly developing technology in the area of hearing impairment.

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