lunes, 6 de agosto de 2012

CDER Small Business Update

The Information Source for Regulated Domestic and International Small Pharmaceutical Business
FDA/CDER's Small Business Assistance

1. Clinical Studies of Safety and Effectiveness of Orphan Products Research Project Grant

FDA is announcing the availability of grant funds for the support of FDA's Office of Orphan Products Development (OPD) grant program. The goal of FDA's OPD grant program is to support the clinical development of products for use in rare diseases or conditions where no current therapy exists or where the proposed product will be superior to the existing therapy. FDA provides grants for clinical studies on safety and/or effectiveness that will either result in, or substantially contribute to, market approval of these products.

For more information, including deadlines, please visit: OPD Grant Program

2. FDA Notification to Industry: Products using oils, glycerin, or protein that were derived from the Jatropha plant may have toxic effects
FDA is notifying the regulated community that oils, glycerin, and proteins commonly used in the production of human and animal food, medical products, cosmetics, and other FDA-regulated products may contain toxins if they are derived from the Jatropha plant.

At this time, the FDA is unaware of any intentional substitution or contamination in FDA-regulated finished products or components derived from the Jatropha plant. However, given the significant overlap among the supply chains of FDA-regulated products, the FDA is advising industry to be aware of the potential for substitution or use of oils, glycerin, and proteins derived from the Jatropha plant. This increased attention to supply chains is important for ingredient suppliers and manufacturers of FDA-regulated products, both in the U.S. and abroad. Suppliers and manufacturers should take steps to prevent the use of ingredients that might be intentionally, or otherwise, adulterated with Jatropha.

Please find additional information at: Jatropha

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