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RegSource Regulatory Page, Provides information for regulatory affairs, fda information, federal register and clinical trials

The RegSource Regulatory page is a comprehensive site to information resources for the pharmaceutical professionals. The site provides links to regulatory and scientific information on the Internet for drug discovery, development and the drug approval process. Links are provided to full text information from the Federal Register (FR) and the information in the FR is focused by therapeutic area. Links are also provided to medical and toxicology information resources by the therapeutic areas. FDA information is neatly broken down by categories in order to find the information quicker without having to search in many different places on the FDA site. Links to several government databases allows searching for biomedical information that is readily available at these sites. The most important feature of this site is the categorization of the pharmaceutical drug and device information that is intuitive and easy to use whether it is for preclinical, clinical or post marketing research.

Categories: Education/Reference, Business
Topics: cber, cder, cdrh, cfr, fda, fda information, federal register and clinical trials, generic drugs, ind, irb, nda, pharmaceutical, provides information for regulatory affairs, regsource regulatory page

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CLS – Clinical summary
CMC – Chemistry – manufacturing – controls
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COA – Certificate of analysis
CoFS – Certificate of Free Sale
CP – Centralized procedure (European Union)
CP – Comparability protocol (USA)
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CTA – Clinical trial authorization
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