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Root Cause Analysis (RCA)
Identifying the root cause for market complaints, out of specifications (OOS), deviations can be challenging, but a number of...
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REGULATORY AFFAIR: LINK BETWEEN COMPANY AND GOVERNMENT AUTHORITY
About Author:Yogeshkumar B. ViradiyaDepartment of Regulatory Affairs, Institute of Management Sciences and Research (IMSR),Nagpur, [email protected] Abstract:Regulatory affair is the...
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Medical Dictionary for Regulatory Activities (MeDRA) by ICH
The factsheet provides information on how organisations can access the Medical Dictionary for Regulatory Activities (MedDRA), as well as...
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A science based approach to topical drug classification system (TCS) – Courtesy of Science Direct
The Biopharmaceutics Classification System (BCS) for oral immediate release solid drug products has been very successful; its implementation in...
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FDA awards $19m in rare disease grants – Courtesy ( PMLiVe)
The US FDA is to encourage research in rare diseases through 15 grants totalling more than $19m. The regulator...
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Drugs@FDA Frequently Asked Questions
1. What is the purpose of Drugs@FDA, and what are its main uses? Drugs@FDA allows you to search for...
