Tag: drug quality
Generic Drug Approval Standards: Safety, Quality, and Strength Requirements Explained
Generic drugs must meet the same safety, quality, and strength standards as brand-name drugs. The FDA requires identical active ingredients, bioequivalence testing, and strict manufacturing controls. Over 90% of U.S. prescriptions are generics, saving $373 billion annually.
Quality concerns: when clinicians question generic manufacturing
Clinicians are raising alarms about generic drug quality, especially when manufactured overseas. Studies show higher adverse event rates for generics made in India compared to U.S.-made versions. Transparency, inspection reform, and domestic production may be key to fixing the system.