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View Full Version : from the FDA Orphan Drug Research Policy



Imogene
06-28-2010, 11:50 AM
If the proposals were to be adopted and implemented, the FDA would make substantially more information about the regulatory process available to the public. The agency would disclose, among other things, when a drug or device is being studied and for what indication, when an application for a new drug or device has been submitted or withdrawn by the sponsor, whether there was a significant safety concern associated with the drug or device that caused the sponsor to withdraw an application, and why the agency did not approve an application. If a report that is published by a sponsor were to contain an incomplete picture about the safety or efficacy of a product, the FDA would be able to provide its analysis to contribute to the scientific discussion.

The task force believes that implementing some of the proposals would accelerate the development process for medical products by allowing companies to learn from the successes and failures of other products. One proposal, for example, would allow the FDA to explain that an orphan drug whose application was abandoned or withdrawn by the sponsor for business reasons may nevertheless represent an important therapeutic advance for a rare disease.</span ft> This information would be of substantial interest to patients with that disease, their families, and their clinicians. It could also encourage additional investment for development of that drug or provide another company with the incentive to purchase and continue with the application.

To read more:
FDA and Transparency (http://www.fda.gov/transparency)