CLINICAL STUDIES OF SAFETY AND EFFECTIVENESS OF ORPHAN PRODUCTS

NIH GUIDE, Volume 22, Number 38, October 22, 1993



P.T. 34



Keywords:

  Pharmaceuticals 

  Pharmacology 



Food and Drug Administration



The Food and Drug Administrations's (FDA) Office of Orphan Products

Development (OPD) announces the availability of Requests for

Applications (RFA) for fiscal year 1994.  OPD research grants are

awarded to support clinical trials on the safety and effectiveness of

orphan products (i.e., those for diseases and conditions affecting a

U.S. population of less than 200,000).  Orphan products are drugs,

biologics, medical devices, and foods for medical purposes.  Grants

of up to $100,000 for up to three years are awarded for studies in

any phase of clinical development and grants of up to $200,000 for up

to two years are awarded for studies in phase 2 or phase 3 of

clinical development.



OPD grants are for clinical studies only, not basic research.  The

goal of our grants program is to encourage clinical development of

new orphan products.  A secondary goal is to encourage clinical

development of orphan indications for already approved products.  To

support these goals, the FDA provides grants to conduct clinical

studies intended to provide data acceptable to the agency that will

either result in or substantially contribute to approval of new

products or new indications.



One requirement for all studies, including studies for new

indications of already approved products, is that the study must be

conducted under an investigational new drug application (IND) or an

investigational device exemption (IDE).  The IND/IDE number is

required to appear on the face page of the application with the title

of the project.  Other proposed submission requirements are evidence

of product availability, evidence of patient availability, and a

well-supported explanation as to why the product is appropriate to

the OPD grant program.  Complete information is provided in the RFA.



Applications must be submitted by December 27, 1993.  The earliest

date for awards will be July 1, 1994.



INQUIRIES



Written and telephone requests for this RFA and requests to have your

name placed on the mailing list for future notices about the OPD

grants program may be directed to:



Patricia Robuck or Carol Wetmore

Office of Orphan Products Development

Food and Drug Administration

5600 Fishers Lane, Room 8-73

Rockville, MD  20857

Telephone:  (301) 443-4903



.

Return to 1993 Index

Return to NIH Guide Main Index

	Office of Extramural Research (OER)			National Institutes of Health (NIH) 9000 Rockville Pike Bethesda, Maryland 20892			Department of Health and Human Services (HHS)
Note: For help accessing PDF, RTF, MS Word, Excel, PowerPoint, Audio or Video files, see Help Downloading Files.