Tag: generic drugs
Bioequivalence Studies: What the FDA Requires Manufacturers to Prove
The FDA requires generic drug manufacturers to prove bioequivalence through rigorous human studies showing their product absorbs at the same rate and extent as the brand-name drug. This ensures safety and effectiveness.
How Generic Drugs Are Made: The Full Manufacturing Process Explained
Generic drugs make up 90% of U.S. prescriptions and save billions annually. Learn how they're made, from reverse engineering the original to strict FDA testing - and why they're just as safe and effective as brand-name drugs.
Orange Book Database: FDA's Approved Drug Products With Therapeutic Equivalence Ratings
The FDA's Orange Book is the official database of approved drug products with therapeutic equivalence ratings, enabling generic drug competition and saving billions in healthcare costs through transparent patent and exclusivity data.
Consumer Language Guides: Making Generic Drug Information Accessible
Learn how consumer language guides help patients understand that generic drugs are just as effective as brand-name versions, with clear facts, real examples, and expert insights to build trust and reduce confusion.