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- Title
Shaping future regulatory enterprise.
- Authors
Potkar, Chandrashekhar
- Abstract
The author discusses the five guidance documents for clinical research that were issued by the Central Drugs Standard Control Organization in India. The benefits of the guidance documents includes transparency, faster review of applications and improve credibility through introduction of independent expert process. The guidance documents can be used by industry and other applicants to ensure alignment potentially impacting review cycle times.
- Subjects
INDIA; CLINICAL medicine research; MEDICAL research; CENTRAL Drugs Standard Control Organization; GUIDELINES
- Publication
Perspectives in Clinical Research, 2012, Vol 3, Issue 2, p45
- ISSN
2229-3485
- Publication type
Editorial
- DOI
10.4103/2229-3485.96441