Regulatory Forum Opinion Piece*

Author:

Neef Natasha1

Affiliation:

1. Bristol Myers Squibb, New Brunswick, New Jersey, USA

Publisher

SAGE Publications

Subject

Cell Biology,Toxicology,Molecular Biology,Pathology and Forensic Medicine

Reference10 articles.

1. Arena pharmaceuticals (2011). August 2011: Arena and Eisai Announce Results of Re-Adjudication of Rat Mammary Tumors from Lorcaserin Carcinogenicity Study Press release available online at http://invest.arenapharm.com/releasedetail.cfm?ReleaseID=597830; accessed December 2013.

2. FDA (Food and Drug Administration). (2010). Lorcaserin FDA advisory committee nonclinical briefing document p. 4. www.fda.gov/./drugs/endocrinologicandmetabolicdrugsadvisorycommittee/ucm225635.pdf Accessed December 2013

3. Panel Discussion: Regulatory Perspective for Pathology Data

4. JSTP (2013). Letter from Executive Committees of the European (ESTP), North American (STP), British (BSTP), French (SFPT), Indian (STP-I), Japanese Societies (JSTP) and the International Federation of Societies of Toxicologic Pathologists (IFSTP) to OECD GLP Operations manager. www.japantoxpath.org/ja/related/peerreview/peerreview20131115.pdf

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