Regulatory Affairs
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 ... Read More
Drug Development and Approval Process | Part II
FDA Approval: What It Means FDA approval of a drug means that data on the drug’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 ... Read More
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 ... Read More
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 ... Read More
Patents and Exclusivity in Pharmaceutical Industry
Did you know that “patent” and “exclusivity” 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 ... Read More
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 ... Read More