Food and Drug Administration Federal Grants

Showing results 26-50 of 70 for Food and Drug Administration federal grants, government grants and loans. For detailed information on a Food and Drug Administration federal grant including eligibility requirements or financial assistance, click the title.

 

Limited Competition for Revision Applications for Pharmacometric Modeling and Simulation for Generic Drugs Evaluation (U01)
The primary objective of original RFA-FD-14-011 (subtopic 2) is to develop pharmacometric modeling and simulation tools for generic drug substitutability evaluation and post marketing risk assessment. The goal is to develop pharmacometic approaches...
www.FederalGrantsWire.com/limited-competition-for-...

Pharmacometric Modeling and Simulation for Long Acting Injectable Products (U01)
The purpose of this project is to: Subtopic 1: conduct physiologically-based pharmacokinetic modeling (PBPK) to relate critical quality attributes to in vivo performance for bioequivalence (BE) evaluation; Subtopic 2: perform population...
www.FederalGrantsWire.com/pharmacometric-modeling-...

Dissolution Methods for Long-acting Periodontal Drug Products (U01)
There is a lack of compendial or biorelevant in vitro drug release assays for long-acting periodontal dosage forms. These products include biodegradable microspheres, in situ forming implants and matrix tablets. The purpose of this study is to...
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Dissolution Methods for Long-acting Levonorgestrel Intrauterine System (U01)
There is a lack of compendial or biorelevant in vitro drug release assays for long-acting contraceptive intrauterine systems. The objective of this study is to investigate dissolution methods, both real time and accelerated conditions, for...
www.FederalGrantsWire.com/dissolution-methods-for-...

National Research Project to Assess State Agricultural Laws, Regulations, and Resources Related to Produce Safety (U01)
The Food and Drug Administration's (FDA), Office of Regulatory Affairs (ORA), Office of Partnerships (OP), is announcing the availability of a Cooperative Agreement to be awarded under a Limited Competition. The estimated amount of funds available...
www.FederalGrantsWire.com/national-research-projec...

Evaluating Predictive Methods and Product Performance in Healthy Adults for Pediatric Patients, Case Study: Furosemide (U01)
Earlier exploratory CDER research projects showed that dissolution and/or solubility of a poorly soluble drug (furosemide was studied as the model drug) was higher in medium containing milk and baby formula than that in standard buffer medium. ...
www.FederalGrantsWire.com/evaluating-predictive-me...

Kidney Health Initiative (R18)
The Food and Drug Administration (FDA), Center for Drug Evaluation and Research (CDER), Office of Medical Policy (OMP) is announcing its intent to accept and consider a single source application for the award of a grant to the American Society of...
www.FederalGrantsWire.com/kidney-health-initiative...

Predictive in vitro Methods for Characterizing Product Performance, Case Study: Furosemide (U01)
This project follows after earlier CDER research projects in which in vitro furosemide dissolution and/or solubility data were collected in various dissolution media such as simulated gastric and intestinal fluids. In two different studies with...
www.FederalGrantsWire.com/predictive-in-vitro-meth...

The Use of Polyethylene Glycol in the Pediatric Population (R01)
The purpose of the proposed study is to better understand the extent of pediatric accumulation of low molecular weight (LMW) species that may be found in PEG 3350 products (e.g., ethylene and diethylene glycol) and of PEG 3350 metabolites. PEG 3350...
www.FederalGrantsWire.com/the-use-of-polyethylene-...

Development of an Integrated Mathematical Model for Comparative Characterization of Complex Molecules (U01)
The goal of this project is to develop a mathematical algorithm or model to integrate in vitro chemical and biological characterization data to determine the degree of sufficiency of in vitro chemical and biological characterization assays, with...
www.FederalGrantsWire.com/development-of-an-integr...

Pharmacokinetic/Pharmacodynamic (PK/PD) Studies of Methylphenidate Extended Release Products in Attention Deficit Hyperactivity Disorder (ADHD) Patients (U01)
The purpose of this project is to conduct a prospective PK/PD study in attention deficit hyperactivity disorder (ADHD) patients to link the PK profiles to the time-course of PD activity of methylphenidate extended release products in order to...
www.FederalGrantsWire.com/pharmacokineticpharmacod...

Post-market surveillance evaluation of authorized generic drug products (U01)
The purpose of this study is to evaluate existing tools and to develop new methods to monitor the drug safety, efficacy, usage, and substitution patterns of model authorized generics in different therapeutic categories in comparison with those of...
www.FederalGrantsWire.com/post-market-surveillance...

Effect of Therapeutic Class on Generic Drug Substitutions (U01)
The purpose of this study is to rank order generic drugs based on therapeutic class with low generic substitution/acceptance rate and analyze factors affecting the generic substitution in each therapeutic class. The outcome of this study will help...
www.FederalGrantsWire.com/effect-of-therapeutic-cl...

Retrospective Analysis on the Impact of Generic Immunosuppressants on Acute Rejection and Long Term Graft Survivals (U01)
Background: Survival after solid organ transplantation has increased substantially due in part to the broad clinical use of immunosuppressants. Immunosuppressive regimens typically include a combination of a calcineurin inhibitor (tacrolimus or...
www.FederalGrantsWire.com/retrospective-analysis-o...

The Effect of Different Preparation Methods on the In Vitro and In Vivo Performance of Solid Dispersion Formulations (U01)
Background: Solid dispersion has been investigated extensively to enhance bioavailability through improving dissolution property of poorly water-soluble drugs. In spite of the great potential for enhancing bioavailability using solid dispersion,...
www.FederalGrantsWire.com/the-effect-of-different-...

Development of realistic in vitro studies to assess robustness of dose counters/indicators in metered dose inhalers (U01)
Metered dose inhalers (MDIs) consist of a formulation, with active ingredient(s) and possibly excipients in a propellant contained in a pressurized canister, and are aerosolized using a valve fitted to an actuator. Dose counters/indicators are an...
www.FederalGrantsWire.com/development-of-realistic...

Evalution of Iron Species in Healthy Subjects treated with Generic and Reference Sodium Ferric Gluconate
Parenteral iron injection products are used to treat anemia, particularly in patients with chronic kidney disease (CKD). There are a number of parenteral iron complex products available in North America: iron sucrose, sodium ferric gluconate, iron...
www.FederalGrantsWire.com/evalution-of-iron-specie...

Pharmacokinetic and Pharmacodynamic (PK-PD) Studies of Cardiovascular Drugs (U01)
Background: Metoprolol is a selective β1 receptor blocker used in treatment of several cardiovascular diseases, especially hypertension. Metoprolol is metabolized primarily by the cytochrome P450 isoform CYP2D6, which is subject to a genetic...
www.FederalGrantsWire.com/pharmacokinetic-and-phar...

Prospective Studies on the Impact of Generic Immunosuppressants on Acute Rejection and Long Term Graft survivals (U01)
Background: Survival after solid organ transplantation has increased substantially due in part to the broad clinical use of immunosuppressants. Immunosuppressive regimens typically include a combination of a calcineurin inhibitor (tacrolimus or...
www.FederalGrantsWire.com/prospective-studies-on-t...

Convener of Discussions on Medical Policy Issues Impacting Drug Development
The Office of Medical Policy (OMP) provides CDER oversight and leadership in the development of medical policy, procedures, and policy initiatives pertaining to drug development, drug approval, bioresearch monitoring, human subject protection and...
www.FederalGrantsWire.com/convener-of-discussions-...

Cigarette Tobacco Reference Products Program (UC2)
FDA's CTP is seeking to develop a cigarette tobacco reference products program that will require significant collaboration and research efforts with outside organizations. The selected organization(s) will develop tobacco reference products...
www.FederalGrantsWire.com/cigarette-tobacco-refere...

Cooperative Agreement to Support the Food and Agriculture Organization (U01)
The overall goal of FAO's Food Safety and Quality Unit (AGN is to improve systems of food safety and quality management, based on scientific principles, that lead to reduced foodborne illness and support fair and transparent trade thereby...
www.FederalGrantsWire.com/cooperative-agreement-to...

Predictive Methods for Characterizing Product Performance in Pediatric Patients, Case Study: Furosemide
This project follows after earlier CDER research projects in which in vitro furosemide dissolution and/or solubility data were collected in various dissolution media such as simulated gastric and intestinal fluids. In two different studies with...
www.FederalGrantsWire.com/predictive-methods-for-c...

Building Research Capacity in Global Tobacco Product Regulation Program (U18)
The Food and Drug Administration announces its intention to accept and consider a single source application for award to the World Health Organization (WHO) for the Building Research Capacity in Global Tobacco Product Regulation Program. The...
www.FederalGrantsWire.com/building-research-capaci...

Cooperative Agreement to Support the North Carolina State University, Prestage Department of Poultry Science and the Piedmont Research Station (U01)
The Food and Drug Administration (FDA) is announcing its intention to receive and consider a single source application for the award of a cooperative agreement in fiscal year 2013 (FY13) to the North Carolina State University, Prestage Department of...
www.FederalGrantsWire.com/cooperative-agreement-to...