Examination & Sample Collection | FDA
What is a field examination? What is a sample collection? Why was my product selected for examination/sampling? How will the FDA notify me if my product will be examined and/or sampled? Can I...
The New Nutrition Facts Label Examples of Different Label Formats FOR REFERENCE ONLY For more information, visit Changes to the Nutrition Facts Label.
These examples demonstrate how RWD sources can be leveraged to support clinical research and generate evidence for marketing submissions for IVDs, and further examples can be found in Appendix...
The following pharmaceutical development report summarizes the development of Example Modified Release (MR) Tablets, 10 mg, a generic version of the reference listed drug (RLD), Brand MR Tablets, 10 mg, indicated for therapeutic relief.
FDA速释制剂 QbD 实例开发：制剂开发前的关键点分析（1）
2023年12月14日 · FDA官网中一个有关药物开发报告的实例，用以说明ANDA申请人如何实施质量源于设计 (QbD)。 该实例的目的是说明申请人在其仿制药开发过程中实施QbD时，可使用的药物开发研究的类型，同时促进探讨OGD在审评中如何使用该信息。
eCTD Sample - Food and Drug Administration
FDA recommends that small businesses submit a successful eCTD sample prior to submitting an actual eCTD submission. While the sample submission is not considered an official submission, it is...
FDA Reveals AI Development Cheat Sheet via Draft Guidances
2025年2月24日 · FDA also offers recommendations for lifecycle management of AI models in the guidance and includes example submission materials to illustrate how device sponsors might operationalize the draft guidance.
Below are example worksheets that define the minimal/ideal profile of the final marketed product and shows the ultimate goals of the proposed therapy development effort such as disease indication, patient population (with details such as symptomatic or pre-symptomatic patients for some genetic diseases), delivery mode, treatment duration ...
FDA QbD实例 速释片 Example QbD for IR Tablet(中英文对照)
这是一个有关药物开发报告的实例，用以说明ANDA申请人如何实施质量源于设计 (QbD)。 该实例的目的是说明ANDA申请人在其仿制药开发过程中实施QbD时，可使用的药物开发研 究的类型，同时促进探讨OGD在审评中如何使用该信息。 Although we have tried to make this example as realistic as possible, the development of a real product may differ from this example.
We used Quality by Design (QbD) to develop generic acetriptan IR tablets that are therapeutically equivalent to the RLD. Initially, the quality target product profile (QTPP) was defined based on the properties of the drug substance, characterization of the RLD product, and consideration of the RLD label and intended patient population.