Regulatory Roundup: FDA Revises Announcement of Tobacco Committee Selection Process, More...

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ePT--the Electronic Newsletter of Pharmaceutical Technology

Also, FDA bans candy and fruit-flavored cigarettes, EMEA moves to improve information management.

The US Food and Drug Administration announced an amendment to its Aug. 26, 2009, Federal Register posting regarding the selection process and nominations for a nonvoting industry representative on the tobacco products scientific advisory committee. The revised date for sending a letter to the agency about participating in the selection process is Oct. 26, 2009. The address for sending a letter was also changed to: Teresa L. Hays, FDA, Center for Tobacco Products, 9200 Corporate Blvd, Rockville, MD 20850-3229, 301.796.3699, Finally, the text in the original announcement regarding the selection process was modified.

In related tobacco-industry news, FDA is making candy and fruit-flavored cigarettes, including cloves, illegal in the United States. The ban is authorized by the new Family Smoking Prevention and Tobacco Control Act and is part of a national effort by FDA to reduce smoking in America, according to an agency release.


The European Medicines Agency (EMEA) intends to fully implement its Product Information Management (PIM) approach, an initiative designed to improve information management, into its centralized procedure within two years, according to a statement of intent from the agency. PIM implementation is currently in a pilot phase where PIM submissions are only accepted subject to prior discussion with the EMEA. The agency's statement, however, has outlined four main milestones that will lead to full implementation of PIM. Those milestones are available on the EMEA website.