Department of Health and Human Services August 6, 2012 – Federal Register Recent Federal Regulation Documents
Results 1 - 7 of 7
New Animal Drugs; Change of Sponsor; Change of Sponsor Address; Azaperone; Miconazole, Polymyxin B, and Prednisolone Suspension
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect a change of sponsor for two new animal drug applications (NADAs) from Janssen Pharmaceutica NV, to Elanco Animal Health, a Division of Eli Lilly & Co. FDA is also amending the animal drug regulations to reflect a change of sponsor's address for Veterinary Service, Inc.
Documents to Support Submission of an Electronic Common Technical Document; Availability
The Food and Drug Administration (FDA) is announcing the availability of the following final versions of documents that support making regulatory submissions in electronic format using the electronic Common Technical Document (eCTD) specifications: ``The eCTD Backbone Files Specification for Module 1, version 2.0'' (which includes the U.S. regional document type definition (DTD), version 3.0) and ``Comprehensive Table of Contents Headings and Hierarchy, version 2.0.'' Supporting technical files are also being made available on the Agency Web site. These documents represent FDA's major updates to Module 1 of the eCTD, which contains regional information. FDA is not prepared at present to accept submissions utilizing this new version because eCTD software vendors need time to update their software to accommodate this information and because its use will require software upgrades within the Agency. FDA estimates it will be able to receive submissions utilizing Module 1 Specifications 2.0 by September 2013, but this is not a firm date and we will give 30 days advance notice to industry.
Clinical Studies of Safety and Effectiveness of Orphan Products Research Project Grant (R01)
The Food and Drug Administration (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. Applicants must include in the application's Background and Significance section documentation to support the assertion that the product to be studied meets the statutory criteria to qualify for the grant and an explanation of how the proposed study will either help support product approval or provide essential data needed for product development.
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