47th TWC, Tob. Work. Conf., 2016, abstr. Panel Discussion 04 U.S. and global leaf and product market situation and outlook Part 2 THOMPSON S. US Tobacco Cooperative, Raleigh NC USA No abstract available....
TSRC, Tob. Sci. Res. Conf., 2016, 70, abstr. 25 What is MedDRA and why is it important for me? QURESHI S. PSI International, Inc., Fairfax, VA, USA The Medical Dictionary for Regulatory activities (MedDRA) terminology and its relevance/ applicability to current tobacco regulations. The drug and biologic Industry now uses the terminology in its clinical trial data and safety databases for...
TSRC, Tob. Sci. Res. Conf., 2016, 70, abstr. 74 How to fulfill statutory requirements on product related health information QURESHI S. PSI International, Inc., Fairfax, VA, USA In 2009 Congress passed and President Obama signed the Family Smoking Prevention and Tobacco Control Act granting FDA authority over select tobacco products. The three Statutory Pathways for new products are Substantial Equivalence Reports, Premarket...
TSRC, Tob. Sci. Res. Conf., 2016, 70, abstr. 75 The what and why of MedDRA QURESHI S. PSI International, Inc., Fairfax, VA, USA The Medical Dictionary for Regulatory activities (MedDRA) is currently recommended by FDA guidance to be used for both premarket and post market adverse event reporting for Drugs and Biologics. In effect this terminology is also used in IND, NDA, and...
Bull. Inf. CORESTA, 1960, 4, p. 17-32., ISSN.0525-6240 The fundamental morphological characteristics for the botanical description of tobacco ANITIA N.; IOAN I. Institute for Food Technology, Bucarest, Romania In the works of most writers dealing with the systematics of cultivars, one is aware of a certain lack of precision as regards the terminology of the various morphological characteristics of tobacco as well as the shape of the plant and its...