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Clinical Pharmacology Review Filing Review for (gel 0.1%) NDA: 22-038 Related IND (s): 51, 246 Sponsors: Upsher-Smith Laboratories (US) Type: NDA filing meeting package Drug: gel 0.1% Dose (s) proposed:
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How to fill out filing review for gel:

01
Start by gathering all the necessary information about the gel product you are reviewing. This includes the brand, the type of gel, and any specific features or benefits.
02
Begin your review by providing a brief introduction about the gel product. Mention its intended use and any notable characteristics that set it apart from other similar products in the market.
03
Next, address the performance and effectiveness of the gel. Share your personal experience using the gel and highlight its positive aspects. Discuss any specific results or benefits you have noticed.
04
Provide detailed information about the application and usage of the gel. Explain how to properly apply it, any precautions or instructions that need to be followed, and any additional tips for best results.
05
Discuss the overall quality of the gel. Analyze its texture, scent, and any other relevant factors that contribute to its overall user experience.
06
Evaluate the packaging and presentation of the gel. Assess its durability, ease of use, and whether it is appealing to the eye.
07
If relevant, compare the gel with similar products in terms of price, ingredients, or performance. Mention any advantages or disadvantages in comparison to other options on the market.
08
Conclude your review by summarizing your overall opinion of the gel. Provide your final thoughts and recommendations for who might benefit from using it.

Who needs filing review for gel:

01
Individuals who are looking for a specific type of gel product (e.g., hair gel, nail gel, skincare gel) and want to make an informed purchasing decision.
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Consumers who rely on reviews and recommendations to assess the quality and effectiveness of beauty and personal care products.
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People who want to learn more about the benefits, usage, and performance of a particular gel product before making a purchase.
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Filing review for gel refers to the regulatory process of submitting a review for the gel product to the relevant authorities.
Manufacturers or distributors of gel products are required to file a filing review for gel before selling or distributing the product.
The process of filling out a filing review for gel may involve providing information about the gel product, its formulation, manufacturing process, safety data, and other relevant details. Specific requirements may vary depending on the jurisdiction.
The purpose of filing review for gel is to ensure the safety, efficacy, and regulatory compliance of gel products before they are made available to the market.
The information to be reported on a filing review for gel may include product specifications, ingredients, manufacturing process details, safety data, labeling, and any required supporting documentation or studies.
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Related Links

center for drug evaluation and research - accessdata.fda.gov
Jan 30, 2018 — Note that upon review of the data submitted, additional tests and/or tightening of the acceptance limits may be required. Release and stability ...
217424Orig1s000 - accessdata.fda.gov
Jan 4, 2024 — NDA/BLA Multi-Disciplinary Review and Evaluation. Application Type NDA. Application Number(s) 217424. Priority or Standard Standard.
center for drug evaluation and research - accessdata.fda.gov
Dec 18, 2023 — Dosage Form(s) / Strength​​ to slightly yellowish, opalescent, non-aqueous gel supplied in 25 mL tubes.

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