Opportunity Information: Apply for RFA FD 15 014
The Food and Drug Administration (FDA) is announcing a grant opportunity aimed at supporting the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH). This initiative focuses on bringing together leading global drug regulatory agencies and pharmaceutical manufacturers to enhance the harmonization of technical standards. The goal is to develop guidelines that ensure medicines are safe, effective, and of high quality, all while optimizing resources.
The outcomes of this effort will encompass a set of internationally recognized guidelines organized into four main areas:
1. **Quality Guidelines**: These guidelines will address pivotal aspects such as stability studies, impurity testing thresholds, and flexible pharmaceutical quality approaches based on Good Manufacturing Practices (GMP) and risk management.
2. **Safety Guidelines**: A comprehensive compilation of safety guidelines will be established to identify potential risks, including carcinogenicity, genotoxicity, and reprotoxicity.
3. **Efficacy Guidelines**: This will focus on the design, conduct, safety, and reporting of clinical trials, including considerations for innovative medicines developed through biotechnology and pharmacogenetic techniques.
4. **Multidisciplinary Guidelines**: Covering cross-cutting subjects that do not neatly fit into the other categories, this area includes the Common Technical Document (CTD) and the creation of Electronic Standards for the Transfer of Regulatory Information (ESTRI).
Overall, the initiative aims to streamline the pharmaceutical development process on a global scale.Apply for RFA FD 15 014
- The Food Drug Administration in the consumer protection food and nutrition health sector is offering a public funding opportunity titled "Harmonization of Technical Requirements for Pharmaceuticals for Human Use (U01)" and is now available to receive applicants.
- Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.103 Food and Drug AdministrationResearch.
- This funding opportunity was created on May 18, 2015 and posted on May 18, 2015.
- Applicants must submit their applications by Sep 30, 2015. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2025.)
- The funding agency has allocated a total of $500,000.00 to eligible and selected applicants.
- Each selected applicant is eligible to receive up to $500,000.00 in funding.
- The number of recipients for this funding is limited to 1 candidate(s).
- Eligible applicants include: Others (see text field entitled Additional Information on Eligibility for clarification).
- Only the following organization is eligible to apply International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH).
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Applicants also applied for:
Applicants who have applied for this opportunity (RFA FD 15 014) also looked into and applied for these:
| Funding Opportunity |
|---|
| Smokeless Tobacco Reference Products (UC2) Apply for RFA FD 15 026 Funding Number: RFA FD 15 026 Agency: Food Drug Administration Category: Consumer Protection Food and Nutrition Health Funding Amount: $3,000,000 |
| Building towards Statistically Based Pharmaceutical Quality Standards (U01) Apply for RFA FD 16 003 Funding Number: RFA FD 16 003 Agency: Food Drug Administration Category: Consumer Protection Food and Nutrition Health Funding Amount: $1,000,000 |
| Evaluating Quality Metrics for Risk Based Surveillance of Drug Manufacturing Operations and Facilities (U01) Apply for RFA FD 16 004 Funding Number: RFA FD 16 004 Agency: Food Drug Administration Category: Consumer Protection Food and Nutrition Health Funding Amount: $500,000 |
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