Postmarketing Surveillance of Generic Drug Usage and Substitution Patterns (U01)

Post Date

March 29th 2013

Application Due Date

May 10th 2013

Funding Opportunity Number

RFA-FD-13-022

CFDA Number(s)

93.103

Funding Instrument Type(s)

Cooperative Agreement

Funding Activity Categories

Consumer Protection
Food and Nutrition
Health

Number of Awards

1

Eligibility Categories

State Governments
County Governments
City or Township Governments
Special District Governments
Independent School Districts
Public and State Controlled Institutions of Higher Education
Federally Recognized Native American Tribal Governments
Public Housing Authorities or Indian Housing Authorities
Non-Federally Recognized Native American Tribal Organizations
Non-Profits With 501 (c) (3) Status With The IRS (Except Higher Education Institutions)
Non-Profits Without 501 (c) (3) Status With The IRS (Except Higher Education Institutions)
Private Institutions of Higher Education
For-Profit Organizations (Except Small Businesses)
Small Businesses
Other

Non-domestic (non-U.S.) Entities (Foreign Institutions) are eligible to apply. Non-domestic (non-U.S.) components of U.S. Organizations are eligible to apply. Foreign components, as defined in the HHS Grants Policy Statement, are allowed.

Funding

• Estimated Total Funding:

  $250000

• Award Range:

  $None - $250000

Grant Description

With the significant increase of generic market share, it is becoming imperative that the public and the scientific community have confidence that the FDA review of generic drugs will ensure that a generic drug is interchangeable with the brand product as well as other generics under all approved indications and conditions of use. Some complex generic products such as vancomycin capsules, sodium ferric gluconate injection, enoxaparin injection and others are approved based on innovative but controversial methods. The purpose of this study is to evaluate existing tools and to develop new methods to proactively monitor the drug safety, efficacy, usage, and substitution patterns of recently approved generic drugs whose approval was controversial and to evaluate if controversy during the approval process affects their acceptance by physicians and patients. The outcome of this study will help assure the public about generic drug safety and efficacy, and support the Agency to continue developing innovative methods for generic drug product approval.

Contact Information

• Agency

  Department of Health and Human Services

• Office:

  Food and Drug Administration

• Agency Contact:

  Lisa Ko
  Grants Management Specialist

• Agency Mailing Address:

  lisa.ko@fda.hhs.gov

• Agency Email Address:

  lisa.ko@fda.hhs.gov

• More Information:

  Link to Full Announcement of RFA-FD-13-022 on the NIH Guide for Contracts and Grants