Meeting with CBER. On May 22, ISAPP’s Executive Science Officer (Mary Ellen Sanders) and Daniel Merenstein MD (Georgetown University) met with Peter Marks MD PhD, Deputy Director of Center for Biologics Evaluation and Research/FDA, and three other CBER representatives, to discuss CBER oversight of probiotic research as investigational new drugs. Concerns were expressed regarding requiring […]
https://isappscience.org/wp-content/uploads/2021/06/ISAPP_LogoRedsign_horz.png00Mary Ellen Sandershttps://isappscience.org/wp-content/uploads/2021/06/ISAPP_LogoRedsign_horz.pngMary Ellen Sanders2014-06-05 00:00:002019-04-18 16:05:23June 5, 2014
The Yogurt in Nutrition Initiative announced a request for research proposals focused on health benefits associated with yogurt consumption. The competition is for one $30,000 USD grant. Research teams from public organizations or researchers at universities or hospitals may apply. The deadline for submission of applications is June 30, 2014. This call is supported by […]
https://isappscience.org/wp-content/uploads/2021/06/ISAPP_LogoRedsign_horz.png00Mary Ellen Sandershttps://isappscience.org/wp-content/uploads/2021/06/ISAPP_LogoRedsign_horz.pngMary Ellen Sanders2014-05-01 00:00:002019-04-18 16:05:23May 1, 2014
ISAPP board members, Gregor Reid and Mary Ellen Sanders, were interviewed by Shane Starling of Nutraingredients for a new documentary film, “MicroWarriors” The Special Edition. The special edition will be a completely re-editied and mastered version from the 2011 probiotic documentary film, “MicroWarriors” The Power of Probiotics. In addition, it will include new graphics and […]
https://isappscience.org/wp-content/uploads/2021/06/ISAPP_LogoRedsign_horz.png00Mary Ellen Sandershttps://isappscience.org/wp-content/uploads/2021/06/ISAPP_LogoRedsign_horz.pngMary Ellen Sanders2014-04-28 00:00:002019-04-18 16:05:23April 28, 2014
ISAPP filed comments with the FDA on its guidance, which requires that essentially all human research to evaluate functional effects of foods be conducted under an IND. ISAPP requested that FDA revise the current guidance to remove their requirement for INDs for human research conducted on foods and that the guidance make it clear that […]
https://isappscience.org/wp-content/uploads/2021/06/ISAPP_LogoRedsign_horz.png00Mary Ellen Sandershttps://isappscience.org/wp-content/uploads/2021/06/ISAPP_LogoRedsign_horz.pngMary Ellen Sanders2014-04-08 00:00:002019-04-18 16:05:24April 8, 2014
Webcasts of the lectures and workshop wrap-ups from the Gut Microbiota for Health World Summit (convened in Miami, March 8-9, 2014) are now available. Click here.
https://isappscience.org/wp-content/uploads/2021/06/ISAPP_LogoRedsign_horz.png00Mary Ellen Sandershttps://isappscience.org/wp-content/uploads/2021/06/ISAPP_LogoRedsign_horz.pngMary Ellen Sanders2014-03-31 00:00:002019-04-18 16:05:24March 31, 2014
ISAPP joined the American Society of Nutrition, Institute of Food Technologists, ILSI-North America and North American Society for Pediatric Gastroenterology, Hepatology and Nutrition in a meeting March 5 with FDA’s Center for Food Safety and Applied Nutrition to share concerns with a guidance that stipulates human research conducted on functional endpoints for foods requires an […]
https://isappscience.org/wp-content/uploads/2021/06/ISAPP_LogoRedsign_horz.png00Mary Ellen Sandershttps://isappscience.org/wp-content/uploads/2021/06/ISAPP_LogoRedsign_horz.pngMary Ellen Sanders2014-03-11 00:00:002019-04-18 16:05:24March 11, 2014
ISAPP will meet March 5 with FDA’s Center for Food Safety and Applied Nutrition to discuss conducting human research on foods. The FDA made it clear in a guidance from September 2013 that human research conducted on functional endpoints for foods requires an investigational new drug (IND) application. However, the FDA re-opened the comment period […]
https://isappscience.org/wp-content/uploads/2021/06/ISAPP_LogoRedsign_horz.png00Mary Ellen Sandershttps://isappscience.org/wp-content/uploads/2021/06/ISAPP_LogoRedsign_horz.pngMary Ellen Sanders2014-02-25 00:00:002019-04-18 16:05:24February 25, 2014
On February 11, ISAPP, represented by Mary Ellen Sanders (executive director), Daniel Merenstein, Greg Leyer (Sr. ISAPP-IAC representative) and Chris Cifelli (Jr. ISAPP-IAC representative), met with Mr. Richard Cleland, Assistant Director, Division of Advertising Practices with the Federal Trade Commission to gain a better understanding of FTCs perspective on conducting research intended to substantiate structure/function […]
https://isappscience.org/wp-content/uploads/2021/06/ISAPP_LogoRedsign_horz.png00Mary Ellen Sandershttps://isappscience.org/wp-content/uploads/2021/06/ISAPP_LogoRedsign_horz.pngMary Ellen Sanders2014-02-24 00:00:002019-04-18 16:05:24February 24, 2014
The FDA is re-opening comments on portions of its Guidance on Determining if Human Research Studies Require an Investigational New Drug Application. ISAPP intends to file comments reflecting concerns that the current guidance (published in final form September 2013) unduly restricts human research on functional properties of foods and supplements, harming U.S. researchers, consumers and […]
https://isappscience.org/wp-content/uploads/2021/06/ISAPP_LogoRedsign_horz.png00Mary Ellen Sandershttps://isappscience.org/wp-content/uploads/2021/06/ISAPP_LogoRedsign_horz.pngMary Ellen Sanders2014-02-05 00:00:002019-04-18 16:05:24February 5, 2014
World Gastroenterology Organisation released a new webcast “Irritable Bowel Syndrome (IBS): What is it, what causes it and can I do anything about it?”; an educational program for the general public. The webcast was developed from the WGO World Digestive Health Day 2012 Campaign and covers the following topics: What is IBS?, How to communicate […]
https://isappscience.org/wp-content/uploads/2021/06/ISAPP_LogoRedsign_horz.png00Mary Ellen Sandershttps://isappscience.org/wp-content/uploads/2021/06/ISAPP_LogoRedsign_horz.pngMary Ellen Sanders2014-01-10 00:00:002019-04-18 16:05:24January 10, 2014
June 5, 2014
/in News /by Mary Ellen SandersMeeting with CBER. On May 22, ISAPP’s Executive Science Officer (Mary Ellen Sanders) and Daniel Merenstein MD (Georgetown University) met with Peter Marks MD PhD, Deputy Director of Center for Biologics Evaluation and Research/FDA, and three other CBER representatives, to discuss CBER oversight of probiotic research as investigational new drugs. Concerns were expressed regarding requiring […]
May 1, 2014
/in News /by Mary Ellen SandersThe Yogurt in Nutrition Initiative announced a request for research proposals focused on health benefits associated with yogurt consumption. The competition is for one $30,000 USD grant. Research teams from public organizations or researchers at universities or hospitals may apply. The deadline for submission of applications is June 30, 2014. This call is supported by […]
April 28, 2014
/in News /by Mary Ellen SandersISAPP board members, Gregor Reid and Mary Ellen Sanders, were interviewed by Shane Starling of Nutraingredients for a new documentary film, “MicroWarriors” The Special Edition. The special edition will be a completely re-editied and mastered version from the 2011 probiotic documentary film, “MicroWarriors” The Power of Probiotics. In addition, it will include new graphics and […]
April 8, 2014
/in News /by Mary Ellen SandersISAPP filed comments with the FDA on its guidance, which requires that essentially all human research to evaluate functional effects of foods be conducted under an IND. ISAPP requested that FDA revise the current guidance to remove their requirement for INDs for human research conducted on foods and that the guidance make it clear that […]
March 31, 2014
/in News /by Mary Ellen SandersWebcasts of the lectures and workshop wrap-ups from the Gut Microbiota for Health World Summit (convened in Miami, March 8-9, 2014) are now available. Click here.
March 11, 2014
/in News /by Mary Ellen SandersISAPP joined the American Society of Nutrition, Institute of Food Technologists, ILSI-North America and North American Society for Pediatric Gastroenterology, Hepatology and Nutrition in a meeting March 5 with FDA’s Center for Food Safety and Applied Nutrition to share concerns with a guidance that stipulates human research conducted on functional endpoints for foods requires an […]
February 25, 2014
/in News /by Mary Ellen SandersISAPP will meet March 5 with FDA’s Center for Food Safety and Applied Nutrition to discuss conducting human research on foods. The FDA made it clear in a guidance from September 2013 that human research conducted on functional endpoints for foods requires an investigational new drug (IND) application. However, the FDA re-opened the comment period […]
February 24, 2014
/in News /by Mary Ellen SandersOn February 11, ISAPP, represented by Mary Ellen Sanders (executive director), Daniel Merenstein, Greg Leyer (Sr. ISAPP-IAC representative) and Chris Cifelli (Jr. ISAPP-IAC representative), met with Mr. Richard Cleland, Assistant Director, Division of Advertising Practices with the Federal Trade Commission to gain a better understanding of FTCs perspective on conducting research intended to substantiate structure/function […]
February 5, 2014
/in News /by Mary Ellen SandersThe FDA is re-opening comments on portions of its Guidance on Determining if Human Research Studies Require an Investigational New Drug Application. ISAPP intends to file comments reflecting concerns that the current guidance (published in final form September 2013) unduly restricts human research on functional properties of foods and supplements, harming U.S. researchers, consumers and […]
January 10, 2014
/in News /by Mary Ellen SandersWorld Gastroenterology Organisation released a new webcast “Irritable Bowel Syndrome (IBS): What is it, what causes it and can I do anything about it?”; an educational program for the general public. The webcast was developed from the WGO World Digestive Health Day 2012 Campaign and covers the following topics: What is IBS?, How to communicate […]