FDA 483 Form & FDA Inspection System: Complete Guide for Pharma Professionals If you work in pharma QA, “FDA 483” is the most feared 1-page form. It’s not a penalty. But if you ignore it, it becomes a Warning Letter, Import Alert, or plant ban. This guide explains what FDA Form 483 is, how FDA … Read more
Generic vs Brand-Name Drugs: Same Medicine, Different Price? Walk into any pharmacy and you’ll see two versions of the same drug on the shelf. One says “Paracetamol 500mg – Brand X” and costs ₹30. The other says “Paracetamol 500mg – Generic” and costs ₹3. Patients always ask the same question: “If the price is so … Read more
The Orange Book lists the following as Patents: The active substances or compounds are claimed in patents. Patents on drug products, including formulation-composition patents. Utilize patents for a certain authorized use or indication of the product. The Bolar amendment to the Drug Price Competition and Patent Term Restoration Act permits a pharmaceutical manufacturer (sponsor) to … Read more
Welcome to WordPress. This is your first post. Edit or delete it, then start writing!
