FDA: Research Grant for Postmarketing Surveillance of Generic Drug Usage and Substitution Patterns

This grant from the FDA aims to evaluate tools and develop new methods to monitor the safety, efficacy, and substitution patterns of recently approved generic drugs, including complex products like vancomycin capsules and enoxaparin injection. The study will assess the impact of controversial approval processes on physician and patient acceptance, ultimately providing valuable insights to ensure public confidence in generic drugs and support the FDA in enhancing innovative approval methods. Closing Date: May 10, 2013.

Opportunity ID: 228554

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General Information

Document Type::	Grants Notice
Funding Opportunity Number::	RFA-FD-13-022
Funding Opportunity Title::	Postmarketing Surveillance of Generic Drug Usage and Substitution Patterns (U01)
Opportunity Category::	Discretionary
Opportunity Category Explanation::
Funding Instrument Type::
Category of Funding Activity::	Consumer Protection
Category Explanation::
Expected Number of Awards::	1
Assistance Listings Number(s)::	93.103 — Food and Drug Administration_Research
Cost Sharing or Matching Requirement::	No
Version::	Synopsis 1
Posted Date::	Mar 29, 2013
Last Updated Date::
Original Closing Date for Applications::	May 10, 2013
Current Closing Date for Applications::	May 10, 2013
Archive Date::	Jun 09, 2013
Estimated Total Program Funding::	$ 250,000
Award Ceiling::	$250,000
Award Floor::	$

Eligibility

Eligible Applicants::

Special district governments

Additional Information on Eligibility::

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.

Additional Information

Agency Name::	Food and Drug Administration
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.
Link to Additional Information::
Grantor Contact Information::	If you have difficulty accessing the full announcement electronically, please contact:

Version History

Version	Modification Description	Updated Date
Synopsis 1

Package Status

Below are CLOSED Opportunity Package(s) no longer available for this Funding Opportunity:

Package No: 1

Assistance Listings:	93.103
Competition ID:
Competition Title:
Opportunity Package ID:	PKG00171774
Opening Date:	Apr 08, 2013
Closing Date:	May 10, 2013
Agency Contact Information::	Lisa Ko
Who Can Apply::	Organization Applicants
mendatory_forms	SF424 (R & R) [V1.2] Project/Performance Site Location(s) [V1.4] Research And Related Other Project Information [V1.3] Research And Related Senior/Key Person Profile (Expanded) [V1.2] Research & Related Budget [V1.1] PHS 398 Cover Page Supplement [V1.4] PHS 398 Research Plan [V1.3] PHS 398 Checklist [V1.3]
optional_forms	R & R Subaward Budget Attachment(s) Form 5 YR 30 ATT [V1.2] PHS Cover Letter [V1.2]