Drugs

Economic Assistance and Incentives for Drug Development

Economic assistance is available in the pre-approval period of drug development for the conduct of clinical trials.  Economic incentives are granted post-approval to reward innovation in drug development.

Economic Assistance, Pre-Approval

Orphan Products Grant Program

FDA's Office of Orphan Products Development (OOPD) Grants Program supports 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.

Charging for Investigational Drugs

21 CFR 312.7 states that a sponsor or investigator may charge for an investigational drug for a treatment use under a treatment protocol or treatment IND under certain conditions.

The final rule, “Charging for Investigational Drugs Under an Investigational New Drug Application,” amends the IND regulation on charging patients for investigational drugs.

PDUFA Waivers

PDUFA Frequently Asked Questions and Information About Waivers describes under which circumstances FDA may grant certain waivers and reductions from drug application fees.

The Guidance for Industry - User Fee Waivers, Reductions, and Refunds for Drug and Biological Products provides recommendations to applicants regarding requests for waivers, refunds, and reductions of user fees for drug products.

Unsolicited Grant Applications

The National Institutes of Health (NIH) Office of Extramural Research offers many funding and grant opportunities. Unsolicited grant applications are those not submitted in response to a published Request for Applications (RFA).  All unsolicited applications (except those that involve veterinary medicine) seeking FDA support should be submitted to the FDA.

Solicited Grant Applications

FDA grant programs for which funds are available solicit competitive applications through Requests for Applications (RFA), which are published in the Federal Register and in other appropriate publications. A list of RFAs can be found on the FDA Grants Opportunities Page.

SBIR/STTR Funding

The Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) programs are two of the largest sources of early-stage capital for innovative small companies in the United States. These programs allow US-owned and operated small businesses to engage in federal research and development (R&D) that has a strong potential for commercialization.

Economic Incentives Post-Approval

Orphan Drug Program

The Orphan Drug Designation Program provides for research grants, tax credits for clinical research, and protocol assistance for the development of drugs for rare diseases and disorders.  The program also provides marketing exclusivity for approved orphan drug products.

Patent Term Restoration

Frequently Asked Questions on the Patent Term Restoration Program(11/1/2000). "Title II of the Drug Price Competition and Patent Term Restoration Act" established a program that extends patent life to compensate patent holders for marketing time lost while developing the product and awaiting government approval. Information on this program is contained in Frequently Asked Questions on the Patent Term Restoration.

New Product Exclusivity

New Drug Product Exclusivity is a system for rewarding research associated with significant innovation by providing for a delay in the submission or effective approval date of certain generic applications.

Pediatric Exclusivity

The Guidance for Industry: Qualifying for Pediatric Exclusivity provides detailed information on how to qualify for pediatric exclusivity. For more information on Pediatric Exclusivity, please see CDER's Pediatric Drug Development website.

180-Day Generic Drug Exclusivity

The provisions of the Drug Price Competition and Patent Term Restoration Act of 1984 (Hatch-Waxman Amendments) which govern the generic drug approval process give 180 days of marketing exclusivity to certain generic drug applicants.

Economic Assistance, Pre-Approval and Post-Approval

Catalog of Federal Domestic Assistance (CFDA)

The CFDA provides access to a database of all Federal programs, plus who to contact and how to apply.

Small Business Administration (SBA)

The SBA website provides a wealth of information on establishing and financing small businesses, including outreach programs for African Americans, Hispanic communities, and women.

Page Last Updated: 04/11/2016
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