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RAPS Publishes 10th Edition of Fundamentals of US Regulatory Affairs, Plus Sector-Specific Books on Medical Devices, Biopharmaceuticals By Zachary Brousseau - Published 16 August 2017

RAPS has published the updated, 10th edition of Fundamentals of US Regulatory Affairs, the most extensive reference available on regulatory affairs for pharmaceuticals, medical devices, biologics and other healthcare products intended for the US market.

Categories: HTML, Articles, Under RAPS, RAPS

Tags: regulatory affairs, text, book, Fundamentals of Regulatory Affairs

China: New Labeling Requirements for Imported Devices By Ansis Helmanis, RegLink - Published 01 October 2012

Categories: China, Labeling

Tags: Imported Devices, English, Chinese, Text, SFDA, Import, Latest News, medical device

Agency Releases Rationale Behind Withdrawal of Avastin's Breast Cancer Indication By Alexander Gaffney - Published 27 February 2012

Categories: FDA

Tags: Text, HER2, Breast Cancer, Roche, Genentech, Avastin, Latest News, Hamburg, decision