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| 1 |
+
---
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| 2 |
+
license: apache-2.0
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| 3 |
+
language:
|
| 4 |
+
- en
|
| 5 |
+
tags:
|
| 6 |
+
- gguf
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| 7 |
+
- ollama
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| 8 |
+
- fda
|
| 9 |
+
- regulatory
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| 10 |
+
- task-extraction
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| 11 |
+
- llama
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| 12 |
+
datasets:
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| 13 |
+
- fda-documents
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| 14 |
+
pipeline_tag: text-generation
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| 15 |
+
model_type: llama
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| 16 |
+
quantization: Q8_0
|
| 17 |
+
---
|
| 18 |
+
|
| 19 |
+
# FDA Task Classifier - GGUF
|
| 20 |
+
|
| 21 |
+
A specialized language model fine-tuned for extracting regulatory tasks from FDA correspondence documents.
|
| 22 |
+
|
| 23 |
+
## Model Details
|
| 24 |
+
|
| 25 |
+
- **Model Type:** LlamaForCausalLM
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| 26 |
+
- **Parameters:** 361.82M
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| 27 |
+
- **Quantization:** Q8_0 GGUF
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| 28 |
+
- **Context Window:** 4096 tokens
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| 29 |
+
- **File Size:** 369 MB
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| 30 |
+
- **License:** Apache 2.0
|
| 31 |
+
|
| 32 |
+
## Quick Start with Ollama
|
| 33 |
+
|
| 34 |
+
The easiest way to use this model is with [Ollama](https://ollama.com):
|
| 35 |
+
|
| 36 |
+
```bash
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| 37 |
+
# Pull the Modelfile from this repo
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| 38 |
+
wget https://huggingface.co/llama-farm/fda-task-classifier-gguf/raw/main/Modelfile
|
| 39 |
+
|
| 40 |
+
# Create the model in Ollama
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| 41 |
+
ollama create fda-task-classifier -f Modelfile
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| 42 |
+
|
| 43 |
+
# Run the model
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| 44 |
+
ollama run fda-task-classifier
|
| 45 |
+
```
|
| 46 |
+
|
| 47 |
+
### Or download manually:
|
| 48 |
+
|
| 49 |
+
```bash
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| 50 |
+
# Download the GGUF file
|
| 51 |
+
wget https://huggingface.co/llama-farm/fda-task-classifier-gguf/resolve/main/model.gguf
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| 52 |
+
|
| 53 |
+
# Create a Modelfile
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| 54 |
+
cat > Modelfile << 'EOF'
|
| 55 |
+
FROM ./model.gguf
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| 56 |
+
|
| 57 |
+
PARAMETER temperature 0.3
|
| 58 |
+
PARAMETER top_p 0.9
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| 59 |
+
PARAMETER top_k 40
|
| 60 |
+
PARAMETER num_ctx 4096
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| 61 |
+
PARAMETER num_predict 512
|
| 62 |
+
|
| 63 |
+
SYSTEM """You are an FDA regulatory task extraction specialist. Your role is to analyze document chunks and identify specific FDA regulatory tasks, requirements, and action items.
|
| 64 |
+
|
| 65 |
+
When analyzing text, focus on:
|
| 66 |
+
- Regulatory submissions and deadlines
|
| 67 |
+
- Clinical trial requirements
|
| 68 |
+
- Manufacturing and quality control tasks
|
| 69 |
+
- Compliance and reporting obligations
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| 70 |
+
- Safety monitoring requirements
|
| 71 |
+
- Documentation and record-keeping tasks
|
| 72 |
+
|
| 73 |
+
Extract tasks in a structured format with:
|
| 74 |
+
- Task description
|
| 75 |
+
- Regulatory category (e.g., clinical, manufacturing, compliance)
|
| 76 |
+
- Priority level if mentioned
|
| 77 |
+
- Deadline if specified
|
| 78 |
+
- Relevant FDA regulation references
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| 79 |
+
|
| 80 |
+
Be precise and factual. Only extract tasks that are explicitly stated or clearly implied in the text."""
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| 81 |
+
EOF
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| 82 |
+
|
| 83 |
+
# Create model in Ollama
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| 84 |
+
ollama create fda-task-classifier -f Modelfile
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| 85 |
+
```
|
| 86 |
+
|
| 87 |
+
## Usage Examples
|
| 88 |
+
|
| 89 |
+
### Simple Task Extraction
|
| 90 |
+
|
| 91 |
+
```bash
|
| 92 |
+
ollama run fda-task-classifier "Extract all FDA regulatory tasks from this text:
|
| 93 |
+
|
| 94 |
+
The sponsor must submit a complete Chemistry, Manufacturing, and Controls (CMC)
|
| 95 |
+
section as part of the IND application within 30 days of this notice. Additionally,
|
| 96 |
+
the clinical protocol must be amended to include enhanced safety monitoring procedures."
|
| 97 |
+
```
|
| 98 |
+
|
| 99 |
+
**Output:**
|
| 100 |
+
```
|
| 101 |
+
1. Submit complete CMC section within 30 days
|
| 102 |
+
Category: Manufacturing/Submission
|
| 103 |
+
Priority: Critical
|
| 104 |
+
Deadline: 30 days from notice
|
| 105 |
+
|
| 106 |
+
2. Amend clinical protocol to include enhanced safety monitoring
|
| 107 |
+
Category: Clinical/Safety
|
| 108 |
+
Priority: High
|
| 109 |
+
```
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| 110 |
+
|
| 111 |
+
### API Usage
|
| 112 |
+
|
| 113 |
+
```python
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| 114 |
+
import requests
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| 115 |
+
|
| 116 |
+
response = requests.post('http://localhost:11434/api/generate', json={
|
| 117 |
+
"model": "fda-task-classifier",
|
| 118 |
+
"prompt": "Extract tasks from: The sponsor should provide updated stability data...",
|
| 119 |
+
"stream": False
|
| 120 |
+
})
|
| 121 |
+
|
| 122 |
+
print(response.json()['response'])
|
| 123 |
+
```
|
| 124 |
+
|
| 125 |
+
## Model Specialization
|
| 126 |
+
|
| 127 |
+
This model is specifically trained to identify:
|
| 128 |
+
|
| 129 |
+
✅ **Submission Requirements**
|
| 130 |
+
- IND/NDA submissions
|
| 131 |
+
- Supplemental applications
|
| 132 |
+
- Annual reports
|
| 133 |
+
|
| 134 |
+
✅ **Clinical Trial Directives**
|
| 135 |
+
- Protocol amendments
|
| 136 |
+
- Safety monitoring
|
| 137 |
+
- Patient enrollment criteria
|
| 138 |
+
|
| 139 |
+
✅ **Manufacturing Tasks**
|
| 140 |
+
- CMC requirements
|
| 141 |
+
- Quality control procedures
|
| 142 |
+
- GMP compliance
|
| 143 |
+
|
| 144 |
+
✅ **Regulatory Compliance**
|
| 145 |
+
- 21 CFR citations
|
| 146 |
+
- Inspection responses
|
| 147 |
+
- CAPA plans
|
| 148 |
+
|
| 149 |
+
✅ **Safety Obligations**
|
| 150 |
+
- Adverse event reporting
|
| 151 |
+
- REMS requirements
|
| 152 |
+
- Risk assessments
|
| 153 |
+
|
| 154 |
+
## Integration with LlamaFarm
|
| 155 |
+
|
| 156 |
+
This model is designed to work seamlessly with [LlamaFarm](https://github.com/llama-farm/llamafarm):
|
| 157 |
+
|
| 158 |
+
```yaml
|
| 159 |
+
# llamafarm.yaml
|
| 160 |
+
runtime:
|
| 161 |
+
models:
|
| 162 |
+
- name: fda-task-classifier
|
| 163 |
+
provider: ollama
|
| 164 |
+
model: fda-task-classifier
|
| 165 |
+
base_url: http://localhost:11434/v1
|
| 166 |
+
|
| 167 |
+
agents:
|
| 168 |
+
- name: fda_document_analyzer
|
| 169 |
+
type: document_analyzer
|
| 170 |
+
model: fda-task-classifier
|
| 171 |
+
description: Extracts FDA regulatory tasks from documents
|
| 172 |
+
```
|
| 173 |
+
|
| 174 |
+
## Performance
|
| 175 |
+
|
| 176 |
+
- **Speed:** ~2-3 seconds per document chunk on M1 Mac
|
| 177 |
+
- **Accuracy:** Optimized for FDA regulatory language
|
| 178 |
+
- **Context:** 4096 tokens (sufficient for most FDA letter sections)
|
| 179 |
+
- **Memory:** ~500MB RAM usage
|
| 180 |
+
|
| 181 |
+
## Files in This Repository
|
| 182 |
+
|
| 183 |
+
- `model.gguf` - Quantized model weights (Q8_0)
|
| 184 |
+
- `Modelfile` - Ollama model configuration
|
| 185 |
+
- `README.md` - Original documentation
|
| 186 |
+
- `USAGE.md` - Detailed usage examples
|
| 187 |
+
- `model_info.json` - Model metadata
|
| 188 |
+
|
| 189 |
+
## Technical Details
|
| 190 |
+
|
| 191 |
+
**Architecture:** LlamaForCausalLM
|
| 192 |
+
**Quantization:** Q8_0 (8-bit quantization)
|
| 193 |
+
**Base Model:** [Undisclosed]
|
| 194 |
+
**Training Data:** FDA correspondence, deficiency letters, meeting minutes
|
| 195 |
+
|
| 196 |
+
**Recommended Parameters:**
|
| 197 |
+
- `temperature: 0.3` - More deterministic outputs
|
| 198 |
+
- `top_p: 0.9` - Focused sampling
|
| 199 |
+
- `num_ctx: 4096` - Optimized context window
|
| 200 |
+
- `num_predict: 512` - Concise task lists
|
| 201 |
+
|
| 202 |
+
## Use Cases
|
| 203 |
+
|
| 204 |
+
1. **Regulatory Document Processing**
|
| 205 |
+
- Extract action items from FDA deficiency letters
|
| 206 |
+
- Identify compliance obligations
|
| 207 |
+
- Track submission deadlines
|
| 208 |
+
|
| 209 |
+
2. **Quality Assurance**
|
| 210 |
+
- Parse inspection observations (483s)
|
| 211 |
+
- Extract CAPA requirements
|
| 212 |
+
- Identify GMP violations
|
| 213 |
+
|
| 214 |
+
3. **Clinical Operations**
|
| 215 |
+
- Extract protocol amendment requirements
|
| 216 |
+
- Identify safety reporting obligations
|
| 217 |
+
- Track clinical trial milestones
|
| 218 |
+
|
| 219 |
+
4. **Automated Compliance**
|
| 220 |
+
- Build task tracking systems
|
| 221 |
+
- Create regulatory calendars
|
| 222 |
+
- Generate compliance reports
|
| 223 |
+
|
| 224 |
+
## Limitations
|
| 225 |
+
|
| 226 |
+
- Optimized for FDA documents (US regulatory text)
|
| 227 |
+
- May not generalize well to other regulatory bodies (EMA, PMDA)
|
| 228 |
+
- Works best with formal regulatory correspondence
|
| 229 |
+
- Limited to English language
|
| 230 |
+
|
| 231 |
+
## Citation
|
| 232 |
+
|
| 233 |
+
If you use this model in your research or application, please cite:
|
| 234 |
+
|
| 235 |
+
```bibtex
|
| 236 |
+
@software{fda_task_classifier_2025,
|
| 237 |
+
title={FDA Task Classifier GGUF},
|
| 238 |
+
author={LlamaFarm Team},
|
| 239 |
+
year={2025},
|
| 240 |
+
url={https://huggingface.co/llama-farm/fda-task-classifier-gguf}
|
| 241 |
+
}
|
| 242 |
+
```
|
| 243 |
+
|
| 244 |
+
## License
|
| 245 |
+
|
| 246 |
+
Apache 2.0 - See LICENSE file for details
|
| 247 |
+
|
| 248 |
+
## Links
|
| 249 |
+
|
| 250 |
+
- **LlamaFarm:** https://github.com/llama-farm/llamafarm
|
| 251 |
+
- **Ollama:** https://ollama.com
|
| 252 |
+
- **Issues:** https://github.com/llama-farm/llamafarm/issues
|
| 253 |
+
- **Discord:** https://discord.gg/RrAUXTCVNF
|