FDA releases draft guidance on diabetes care and prevention
WASHINGTON The Food and Drug Administration is making a new draft guidance available for the pharmaceutical industry called, “Diabetes Mellitus: Developing Drugs and Therapeutic Biologics for Treatment and Prevention.”
Draft guidances provide recommendations for developing drugs and therapeutic biologics. Because the FDA recognizes the scope of the diabetes mellitus problem, the agency has recognized the need for new products that can be used as part of a comprehensive treatment strategy in the treatment and prevention of diabetes.
According to the FDA, the draft guidance provides recommendations on the following topics related to the treatment of type 1 and type 2 diabetes mellitus:
- Diabetes-specific preclinical studies;
- Different study designs in different phases of drug development for both type 1 and type 2 diabetes
- Study population considerations in different phases of development;
- Specific statistical issues related to development of drugs and biologics intended for the treatment of diabetes.
In addition to the draft guidance, FDA plans to convene a public advisory committee meeting to discuss new approaches for the development of products for the treatment of diabetes.
Study shows only strict compliance to ginko biloba regimen has effect
BALTIMORE Neurology, the official journal of the American Academy of Neurology, on Wednesday published a study that found that ginkgo biloba extract neither altered the risk of progression from normal to clinical dementia rating, nor protected against a decline in memory function unless those supplementing with gingko were strictly compliant with a regimen of gingko.
In addition, more stroke and transient ischaemic attacks were observed among the group supplementing with ginkgo biloba, which may necessitate further study to confirm the findings, study authors suggested.
The randomized, placebo-controlled, double-blind, 42-month pilot study was conducted in 188 cognitively-intact subjects 85 and older. The amount of ginkgo used to supplement was not disclosed in the published abstract.
In a secondary analysis, where study authors controlled the medication adherence level, the group supplementing with gingko did have a lower risk of progression from normal to clinical dementia rating, and a smaller decline in memory scores.
“Results of larger prevention trials taking into account medication adherence may clarify the effectiveness of [gingko supplementation],” study authors concluded. “[And] more stroke and TIA cases observed among the GBE group requires further study to confirm.”
Tahitian Noni Juice with Acerola available in limited edition
PROVO, Utah Tahitian Noni International, on Thursday announced the availability of a limited edition super fruit blend of Tahitian Noni Juice with Acerola, a juice that combines the benefits of noni with Acerola for an immune boost.
“Tahitian Noni Juice is the No. 1 selling noni-juice product in the world,” stated Shon Whitney, vice president of marketing for Tahitian Noni International. “This new flavor addition will give people the refreshing taste of Acerola and provide another reason to drink Tahitian Noni Juice for those who are looking for a high source of natural vitamin C.”