 |
The Division of Drug Information (DDI) is CDER's focal point for public inquiries. We serve the public by providing information on human drug products and drug product regulation by FDA.
As part of the Generic Drug User Fee Amendments (GDUFA) of 2012, The Food and Drug Administration held a public meeting on June 21, 2013 to seek input from a variety of stakeholders in developing the FY 2014 Regulatory Science Initiatives.
The resulting FY 2014 research priorities are: post-market evaluation of generic drugs, equivalence of complex products, equivalence of locally-acting products, therapeutic equivalence evaluation and standards, and computational and analytical tools. Scientific research opportunities funded through the GDUFA Regulatory Science Research Program are announced on Grants.gov and FedBizOpps.gov.
Direct links to the FY 2014 announcements are listed below.
- Dissolution Methods for Semisolid Ocular Drug Products (Applications due by May 1, 2014)
- Dissolution Methods for Microsphere and Implant Drug Products (Applications due by May 1, 2014)
- Dissolution Methods for Suspension and Emulsion Ocular Drug Products (Applications due by May 7, 2014)
- Pharmacometric Modeling and Simulation for Generic Drugs Evaluation (Applications due by June 1, 2014)
- Physiologically Based Absorption and Pharmacokinetic Modeling and Simulation for Non-gastrointestinally Absorbed Drug Products in Humans (Applications due by June 1, 2014)
- Characterization of Critical Quality Attributes for Semisolid Topical Drug Products (Applications due by June 1, 2014)
- Evaluation of In Vitro Release Methods for Liposomal Drug Products (U01) (Applications due by June 1, 2014)
For more information, please see http://1.usa.gov/1oNALjo and http://1.usa.gov/1oNzCbs.
This is an automated message delivery system. Replying to this message will not reach DDI staff. If you have comments or questions, please contact us at: 1-888-INFO FDA (1-888-463-6332) or (301) 796-3400 from 8:00 am - 4:30 pm Monday - Friday. You can also email us at druginfo@fda.hhs.gov.
- For additional drug information, please visit the DDI Web page.
- For up-to-date drug information, follow the FDA’s Division of Drug Information on Twitter: FDA_Drug_Info
- This service is provided to you at no charge by the U.S. Food & Drug Administration (FDA).
| This email was sent to kostikblog@ukr.net using GovDelivery, on behalf of: U.S. Food & Drug Administration (FDA) · 10903 New Hampshire Ave · Silver Spring, MD 20993 · 800-439-1420 |  |
