Regulatory Affairs

Estimated Time Frames for Obtaining FDA Authorization
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Estimated Time Frames for Obtaining FDA Authorization

๐—•๐—ถ๐—ผ๐—น๐—ผ๐—ด๐—ถ๐—ฐ๐˜€ The approval timeline for a biologic can vary depending on the complexity of the product and the data required to support its safety and effectiveness. ๐—ฃ๐—ฟ๐—ฒ-๐—œ๐—ก๐—— ๐—ฑ๐—ฒ๐˜ƒ๐—ฒ๐—น๐—ผ๐—ฝ๐—บ๐—ฒ๐—ป๐˜: 1-2 years๐—œ๐—ก๐——: 1-2 years๐—–๐—น๐—ถ๐—ป๐—ถ๐—ฐ๐—ฎ๐—น ๐˜๐—ฟ๐—ถ๐—ฎ๐—น๐˜€: 3-7 years๐—•๐—Ÿ๐—” ๐˜€๐˜‚๐—ฏ๐—บ๐—ถ๐˜€๐˜€๐—ถ๐—ผ๐—ป: 6 months๐—™๐——๐—” ๐—ฟ๐—ฒ๐˜ƒ๐—ถ๐—ฒ๐˜„: 6-12 months๐—ง๐—ผ๐˜๐—ฎ๐—น ๐—ฎ๐—ฝ๐—ฝ๐—ฟ๐—ผ๐˜ƒ๐—ฎ๐—น ๐˜๐—ถ๐—บ๐—ฒ: 5-10 years ๐—•๐—ถ๐—ผ๐˜€๐—ถ๐—บ๐—ถ๐—น๐—ฎ๐—ฟ๐˜€ The approval timeline for a biosimilar is typically shorter…

FDA Requirements For OTC Drugs
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FDA Requirements For OTC Drugs

An over-the-counter (OTC) product can be described as a medicine available for self-medication that does not require a doctorโ€™s prescription. Self-medication is a common treatment of many routine health problems such as headaches, allergies, and skin conditions. OTC drugs are designed, labeled, and approved by various regulatory agencies around the world for use without medical…

Drug Development and Approval Process | Part III
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Drug Development and Approval Process | Part III

When studying a new drug, it can sometimes take many years to learn whether a drug actually provides a real effect on how a patient survives, feels, or functions. A positive therapeutic effect that is clinically meaningful in the context of a given disease is known as clinical benefit. Mindful of the fact that it…

Drug Development and Approval Process | Part II
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Drug Development and Approval Process | Part II

FDA Approval: What It Means FDA approval of a drug means that data on the drugโ€™s effects have been reviewed by CDER, and the drug is determined to provide benefits that outweigh its known and potential risks for the intended population. The drug approval process takes place within a structured framework that includes: 1. Analysis…

Drug Development and Approval Process | Part I
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Drug Development and Approval Process | Part I

Developing New Drugs American consumers benefit from having access to the safest and most advanced pharmaceutical system in the world. The main consumer watchdog in this system is FDA’s Center for Drug Evaluation and Research (CDER). Drug companies seeking to sell a drug in the United States must first test it. The company then sends…

Regulatory Guidelines for CSV

Regulatory Guidelines for CSV

Embarking on the path to a successful Computer System Validation (CSV) roadmap begins with a solid understanding of the applicable regulatory requirements within your industry and region. Investing the time to understand which regulations you must comply with, which are advantageous, and which, are the gold standard, is a crucial starting point for your CSV…

Patents and Exclusivity in Pharmaceutical Industry

Patents and Exclusivity in Pharmaceutical Industry

Did you know that โ€œpatentโ€ and โ€œexclusivityโ€ are two of the most commonly searched terms on the FDA website? Generics account for more than 80% of prescription drugs in the US, and that number continues to grow. With approaching patent expirations of several top selling prescription brand-name drugs, sponsors of innovator drug products and generic…

Drug Master File (DMF) in Pharmaceutical Industry

Drug Master File (DMF) in Pharmaceutical Industry

Drug Master File (DMF) is a package of confidential, proprietary assets, specifying the formula, processes, materials, test methods, and other information relevant to the manufacture of product used in the composition, packaging, and/or processing of pharmaceuticals and/or biologics. Types of DMFs Type I: Manufacturing Site, Facilities, Operating Procedures, and Personnel Type II: Drug substance and…